scholarly journals Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study

10.2196/18915 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e18915
Author(s):  
Britta Larsen ◽  
Stephanie Micucci ◽  
Sheri J Hartman ◽  
Gladys Ramos
Keyword(s):  
Physical Activity ◽  
Pregnant Women ◽  
Consumer Satisfaction ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Clinic Visit ◽  
Potential Efficacy

Background Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted. Objective The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health–based physical activity intervention for pregnant women with diabetes. Methods Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks’ gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time. Results The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228). Conclusions High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy. Trial Registration ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377

scholarly journals Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study (Preprint)

2020 ◽  
Author(s):  
Britta Larsen ◽  
Stephanie Micucci ◽  
Sheri J Hartman ◽  
Gladys Ramos
Keyword(s):  
Physical Activity ◽  
Pregnant Women ◽  
Consumer Satisfaction ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Clinic Visit ◽  
Potential Efficacy

BACKGROUND Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted. OBJECTIVE The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health–based physical activity intervention for pregnant women with diabetes. METHODS Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks’ gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time. RESULTS The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228). CONCLUSIONS High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy. CLINICALTRIAL ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377

scholarly journals Web-Based Physical Activity Intervention for Latina Adolescents: Feasibility, Acceptability, and Potential Efficacy of the Ni�as Saludables Study (Preprint)

2017 ◽  
Author(s):  
Britta Larsen ◽  
Tanya Benitez ◽  
Mayra Cano ◽  
Shira S Dunsiger ◽  
Bess H Marcus ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Activity Intervention ◽  
Low Cost ◽  
Pilot Trial ◽  
Web Content ◽  
Web Based ◽  
Latina Adolescents ◽  
Baseline Activity ◽  
Potential Efficacy

BACKGROUND Physical activity is markedly low in Latina adolescents, yet few physical activity interventions have been attempted in this population. Web-based interventions can incorporate theory-based components, be appealing to adolescents, and have potential for low-cost dissemination. OBJECTIVE This study aimed to assess the feasibility, acceptability, and potential efficacy of a Web-based physical activity intervention for Latina adolescents in a single-arm pilot trial. METHODS A total of 21 Latina adolescents (aged 12-18 years) who could read and write in English and were underactive (<90 min/week) participated in a 12-week, theory-informed Web-based physical activity intervention. The intervention website was modified from a previous Web-based intervention for Latina adults. Web content was individually tailored based on the responses to monthly questionnaires. Feasibility was measured by recruitment, retention, and adherence/engagement, and acceptability was measured by satisfaction surveys. Physical activity was measured at baseline and follow-up (12 weeks) using the 7-day physical activity recall (PAR) interview and accelerometers. RESULTS Baseline activity as measured by the 7-day PAR and accelerometers was 24.7 (SD 26.11) and 24.8 (SD 38.3) min/week, respectively. At 12 weeks, 19 participants (90%, 19/21) returned. Adherence and engagement with materials were low, but 72% (15/21) of the participants indicated that they were satisfied with the intervention. Activity at 12 weeks increased by 58.8 (SD 11.33) min/week measured by the 7-day PAR (P<.001). Accelerometer-measured activity did not increase. Activities reported at follow-up were more varied than at baseline, including some activities measured poorly by accelerometers (eg, biking and swimming). Participants suggested simplifying the website and incorporating other technologies. CONCLUSIONS Good retention and increases in self-reported activity suggest a promising approach to delivering a physical activity intervention to Latina adolescents. Incorporating other technologies, such as smartphone apps, could make the intervention more engaging, acceptable, and effective.

scholarly journals Salud paso por paso : a culturally-tailored physical activity intervention with hispanic adults with type 2 diabetes mellitus

2021 ◽  
Author(s):  
◽  
Julio Cesar Loya
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Tailored ◽  
Hispanic Adults

Limited information is available regarding culturally-tailored physical activity (PA) interventions for Hispanic adults with type 2 diabetes mellitus (T2DM). A community-partnered approach was used to examine a novel culturally-tailored PA intervention using a pre-post, no control group design. The intervention consisted of six weekly 45-minute sessions for participants to engage in PA led by the researcher. A total of 21 individuals participated in the study. The typical participant was a 53-year-old female (90 percent) Hispanic adult living with T2DM with low acculturation. On average, before the intervention, the participants walked 10,285 (sd 14,779) steps per week with 43.4 (sd 68.1) minutes of PA per week. Despite implementation during the COVID-19 pandemic, the intervention was feasible and acceptable, and 19 (90.5 percent) participants attended all intervention sessions. There were significant increases in steps per week (p=0.007; d=1.03) and minutes of PA per week (p=0.000; d=1.62). Findings suggest that Salud Paso por Paso has promise as a strategy to enhance PA behaviors in the priority population. A randomized, controlled trial with a larger study sample is warranted to examine efficacy and impact on the diabetes health outcomes of Hispanic adults with T2DM.

scholarly journals Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036277 ◽  
Author(s):  
Kaushik Chattopadhyay ◽  
Pallavi Mishra ◽  
Kavita Singh ◽  
Tess Harris ◽  
Mark Hamer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Plasma Glucose ◽  
Plasma Glucose Level ◽  
Controlled Trial ◽  
Randomised Controlled

IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.InterventionYOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.Methods and analysisThis is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18–74 years, at high risk of T2DM (fasting plasma glucose level 5.6–6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20–30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.Ethics and disseminationEthics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration numberCTRI/2019/05/018893.

scholarly journals A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Melinda S Bender ◽  
Bruce A Cooper ◽  
Linda G Park ◽  
Sara Padash ◽  
Shoshana Arai
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Phase 1 ◽  
Intervention Group ◽  
Filipino Americans ◽  
Phase 2 ◽  
Filipino American ◽  
Potential Efficacy

BACKGROUND Filipino Americans have a high prevalence of obesity, type 2 diabetes (T2D), and cardiovascular disease compared with other Asian American subgroups and non-Hispanic whites. Mobile health (mHealth) weight loss interventions can reduce chronic disease risks, but these are untested in Filipino Americans with T2D. OBJECTIVE The objective of this study was to assess feasibility and potential efficacy of a pilot, randomized controlled trial (RCT) of a culturally adapted mHealth weight loss lifestyle intervention (Pilipino Americans Go4Health [PilAm Go4Health]) for overweight Filipino Americans with T2D. METHODS This was a 2-arm pilot RCT of the 3-month PilAm Go4Health intervention (phase 1) with an active waitlist control and 3-month follow-up (phase 2). The waitlist control received the PilAm Go4Health in phase 2, whereas the intervention group transitioned to the 3-month follow-up. PilAm Go4Health incorporated a Fitbit accelerometer, mobile app with diary for health behavior tracking (steps, food/calories, and weight), and social media (Facebook) for virtual social support, including 7 in-person monthly meetings. Filipino American adults ≥18 years with T2D were recruited from Northern California. Feasibility was measured by rates of recruitment, engagement, and retention. Multilevel regression analyses assessed within and between group differences for the secondary outcome of percent weight change and other outcomes of weight (kg), body mass index (BMI), waist circumference, fasting plasma glucose, HbA1c, and steps. RESULTS A total of 45 Filipino American adults were enrolled and randomized. Mean age was 58 (SD 10) years, 62% (28/45) were women, and mean BMI was 30.1 (SD 4.6). Participant retention and study completion were 100%, with both the intervention and waitlist group achieving near-perfect attendance at all 7 intervention office visits. Groups receiving the PilAm Go4Health in phase 1 (intervention group) and phase 2 (waitlist group) had significantly greater weight loss, −2.6% (−3.9 to −1.4) and −3.3% (−1.8 to −4.8), respectively, compared with the nonintervention group, resulting in a moderate to small effect sizes (d=0.53 and 0.37, respectively). In phase 1, 18% (4/22) of the intervention group achieved a 5% weight loss, whereas 82% (18/22) maintained or lost 2% to 5% of their weight and continued to maintain this weight loss in the 3-month follow-up. Other health outcomes, including waist circumference, BMI, and step counts, improved when each arm received the PilAm Go4Health, but the fasting glucose and HbA1c outcomes were mixed. CONCLUSIONS The PilAm Go4Health was feasible and demonstrated potential efficacy in reducing diabetes risks in overweight Filipino Americans with T2D. This study supports the use of mHealth and other promising intervention strategies to reduce obesity and diabetes risks in Filipino Americans. Further testing in a full-scale RCT is warranted. These findings may support intervention translation to reduce diabetes risks in other at-risk diverse populations. CLINICALTRIAL Clinicaltrials.gov NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived by WebCite at http://www.webcitation.org/6vDfrvIPp)

scholarly journals User Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah Edney ◽  
Jillian C Ryan ◽  
Tim Olds ◽  
Courtney Monroe ◽  
François Fraysse ◽  
...  
Keyword(s):  
Physical Activity ◽  
Mixed Models ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
User Engagement ◽  
User Characteristics ◽  
Objectively Measured ◽  
Objectively Measured Physical Activity ◽  
Super Users

BACKGROUND The success of a mobile phone app in changing health behavior is thought to be contingent on engagement, commonly operationalized as frequency of use. OBJECTIVE This subgroup analysis of the 2 intervention arms from a 3-group randomized controlled trial aimed to examine user engagement with a 100-day physical activity intervention delivered via an app. Rates of engagement, associations between user characteristics and engagement, and whether engagement was related to intervention efficacy were examined. METHODS Engagement was captured in a real-time log of interactions by users randomized to either a gamified (n=141) or nongamified version of the same app (n=160). Physical activity was assessed via accelerometry and self-report at baseline and 3-month follow-up. Survival analysis was used to assess time to nonuse attrition. Mixed models examined associations between user characteristics and engagement (total app use). Characteristics of super users (top quartile of users) and regular users (lowest 3 quartiles) were compared using <italic>t</italic> tests and a chi-square analysis. Linear mixed models were used to assess whether being a super user was related to change in physical activity over time. RESULTS Engagement was high. Attrition (30 days of nonuse) occurred in 32% and 39% of the gamified and basic groups, respectively, with no significant between-group differences in time to attrition (<italic>P</italic>=.17). Users with a body mass index (BMI) in the healthy range had higher total app use (mean 230.5, 95% CI 190.6-270.5; <italic>F</italic><sub>2</sub>=8.67; <italic>P</italic>&lt;.001), compared with users whose BMI was overweight or obese (mean 170.6, 95% CI 139.5-201.6; mean 132.9, 95% CI 104.8-161.0). Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; <italic>F</italic><sub>1</sub>=6.385; <italic>P</italic>=.01) than younger users (mean 155.6, 95% CI 128.5-182.6). Super users were 4.6 years older (t<sub>297</sub>=3.6; <italic>P</italic>&lt;.001) and less likely to have a BMI in the obese range (χ<sup>2</sup><sub>2</sub>=15.1; <italic>P</italic>&lt;.001). At the 3-month follow-up, super users were completing 28.2 (95% CI 9.4-46.9) more minutes of objectively measured physical activity than regular users (<italic>F</italic><sub>1,272</sub>=4.76; <italic>P</italic>=.03). CONCLUSIONS Total app use was high across the 100-day intervention period, and the inclusion of gamified features enhanced engagement. Participants who engaged the most saw significantly greater increases to their objectively measured physical activity over time, supporting the theory that intervention exposure is linked to efficacy. Further research is needed to determine whether these findings are replicated in other app-based interventions, including those experimentally evaluating engagement and those conducted in real-world settings.

scholarly journals Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030902 ◽  
Author(s):  
Justin M Guagliano ◽  
Helen Elizabeth Brown ◽  
Emma Coombes ◽  
Elizabeth S Haines ◽  
Claire Hughes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Family Members ◽  
Physical Activity Promotion ◽  
Activity Promotion ◽  
Ethical Approval ◽  
Family Based ◽  
Randomised Controlled

IntroductionFamily-based physical activity (PA) interventions present a promising avenue to promote children’s activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.Methods and analysisFRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3–6 (aged 7–11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to ‘travel’ to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families’ website engagement will also be explored.Ethics and disseminationThis study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.Trial registration numberISRCTN12789422

scholarly journals User Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial

10.2196/14645 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14645 ◽  
Author(s):  
Sarah Edney ◽  
Jillian C Ryan ◽  
Tim Olds ◽  
Courtney Monroe ◽  
François Fraysse ◽  
...  
Keyword(s):  
Physical Activity ◽  
Mixed Models ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
User Engagement ◽  
User Characteristics ◽  
Objectively Measured ◽  
Objectively Measured Physical Activity ◽  
Super Users

Background The success of a mobile phone app in changing health behavior is thought to be contingent on engagement, commonly operationalized as frequency of use. Objective This subgroup analysis of the 2 intervention arms from a 3-group randomized controlled trial aimed to examine user engagement with a 100-day physical activity intervention delivered via an app. Rates of engagement, associations between user characteristics and engagement, and whether engagement was related to intervention efficacy were examined. Methods Engagement was captured in a real-time log of interactions by users randomized to either a gamified (n=141) or nongamified version of the same app (n=160). Physical activity was assessed via accelerometry and self-report at baseline and 3-month follow-up. Survival analysis was used to assess time to nonuse attrition. Mixed models examined associations between user characteristics and engagement (total app use). Characteristics of super users (top quartile of users) and regular users (lowest 3 quartiles) were compared using t tests and a chi-square analysis. Linear mixed models were used to assess whether being a super user was related to change in physical activity over time. Results Engagement was high. Attrition (30 days of nonuse) occurred in 32% and 39% of the gamified and basic groups, respectively, with no significant between-group differences in time to attrition (P=.17). Users with a body mass index (BMI) in the healthy range had higher total app use (mean 230.5, 95% CI 190.6-270.5; F2=8.67; P<.001), compared with users whose BMI was overweight or obese (mean 170.6, 95% CI 139.5-201.6; mean 132.9, 95% CI 104.8-161.0). Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F1=6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6). Super users were 4.6 years older (t297=3.6; P<.001) and less likely to have a BMI in the obese range (χ22=15.1; P<.001). At the 3-month follow-up, super users were completing 28.2 (95% CI 9.4-46.9) more minutes of objectively measured physical activity than regular users (F1,272=4.76; P=.03). Conclusions Total app use was high across the 100-day intervention period, and the inclusion of gamified features enhanced engagement. Participants who engaged the most saw significantly greater increases to their objectively measured physical activity over time, supporting the theory that intervention exposure is linked to efficacy. Further research is needed to determine whether these findings are replicated in other app-based interventions, including those experimentally evaluating engagement and those conducted in real-world settings. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617000113358; https://www.anzctr.org.au/ACTRN12617000113358.aspx

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