Efficacy of a web-based adaptation of the Diabetes Prevention Program with online nutritional counselling for weight loss during the holiday season among adults with overweight or obesity: a pilot randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Alma L Ruelas ◽  
Michelle M Haby ◽  
Teresita De Jesús Martinez-Contreras ◽  
Julian Esparza-Romero ◽  
Maria Del Carmen Candia-Plata ◽  
...  

BACKGROUND The holiday season is considered a high-risk period for weight gain, especially for people with overweight or obesity. However, few evaluated interventions have focused on preventing weight gain during this period and, to our knowledge, none have intended to treat obesity. OBJECTIVE To evaluate the efficacy of a web-based intervention adapted from the Diabetes Prevention Program (DPP-web) for weight loss in Mexican adults with overweight or obesity at 3 months compared to a waiting list control group. METHODS A pilot randomised controlled trial with parallel groups (DPP-web and waiting list) targeting adults with overweight or obesity. Participants were recruited using Facebook ads. A web-based app was designed for the delivery of the Cognitive Behavioural Sessions (CBS) of the DPP-web, and Facebook video calls were used for weekly online nutrition counselling sessions (NCS) by a trained dietitian. The primary outcome was the change in body weight at 3 months. The secondary outcomes were the changes in other anthropometric variables, systolic and diastolic blood pressure, depression score and health-related quality of life scores at 3 months. All measurements were conducted in a university clinic by the same technician, who was blinded to group allocation. The study was conducted between 24 September 2018 and 20 January 2019, which allowed the evaluation of the effect of the program during the holiday season. RESULTS A total of 30 participants aged 35.2 (SD 10.9) years and with a mean BMI of 33.8 (SD 5.58) kg/m2 were randomized (15 DPP-web, 15 waiting list). A retention rate of 80% was observed at 3 months (12 DPP-web, 12 waiting list). All 30 participants who started the intervention were included in the intention to treat analysis. An average weight loss of 1.57 (SD 3.54) kg was observed in the DPP-web group, compared to an average weight gain of 2.18 (SD 4.22) kg in the control group (P=.01). The estimated difference between groups at 3 months was 3.75 kg (95% CI 0.84, 6.67). CONCLUSIONS The DPP-web supported with online nutrition counselling has a significant effect on body weight, specifically preventing weight gain in adults with overweight or obesity during the holiday season. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03629301.

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Carl J. Brandt ◽  
Vibeke Brandt ◽  
Mathilde Pedersen ◽  
Dorte Glintborg ◽  
Søren Toubro ◽  
...  

Background. Internet-based complex interventions aiming to promote weight loss and optimize healthy behaviors have attracted much attention. However, evidence for effect is lacking. Obesity is a growing problem, resulting in an increasing demand for cost efficient weight loss programs suitable for use on a large scale, for example, as part of standard primary care. In a previous pilot project by Brandt et al. (2011) without a control group, we examined the effects of online dietician counseling and found an average weight loss of 7.0 kg (95% CI: 4.6 to 9.3 kg) after 20 months. Aims and Methods. To analyze the effects of a complex intervention using trained dieticians in a general practice setting combined with internet-based interactive and personalized weight management support compared with conventional advice with a noninteractive internet support as placebo treatment in 340 overweight patients during a 2-year period. Primary endpoints are weight loss and lowering of cholesterol (LDL). We will also explore patients’ sociodemographics and use of the intervention as well as the health professionals’ views and perceptions of the intervention (their role and the advice and support that they provide). Perspective. The project will generate knowledge on the cost-effectiveness of a complex internet-based intervention in a general practice setting and on barriers and acceptability among professionals and patients.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15127-15127
Author(s):  
M. Raida ◽  
H. Mestrom ◽  
H. Delbrück

15127 Background: Postoperative nutritional status is a major factor determining the outcome after gastrectomy for gastric cancer. However, weight loss is a regular consequence after gastrectomy for gastric cancer. This weight reduction occurs during the first months, after which the weight curve seems to stabilize. Aim of this study was to determine the effect of maltodextrin supplemented diet on postgastrectomy weight loss. Methods: In 2005 we introduced a liquid supplementation of maltodextrin to the conventional solid dietary schedule of patients who had underwent gastrectomy for gastric cancer. Between 01/2005 and 6/2006 87 consecutive patients with gastric cancer were included in the study. They were admitted to our hospital for a 3–4 weeks period of oncological rehabilitation, median age was 70 years, gastrectomy had been carried out up to 8 months before study inclusion. Oral nutrition followed the recommended dietary guidelines to avoid postgastrectomy dumping syndrome. This diet was supplemented with 150 g of maltodextrin, dissolved in 1 litre of tea (600 kcal). Weight changes in this study population were compared to a control population of 65 consecutive patients with gastric cancer who had been admitted to our hospital between 01/1992 and 12/1993, matching the same inclusion criteria as the study population but fed without the supplementation of maltrodextrin. Results: During the 3–4 weeks rehabilitation period patients from the maltodextrin study group were able to reach an average weight gain of 407g while patients from the control group lost in average 352 g during the same time span. We observed that weight gain substantially improved the psychological condition of the patients. Postgastrectomy dumping syndrome was similar in both groups depending on strict control of the dietary schedule. Conclusions: We conclude that a maltodextrin supplemented diet can effectively prevent postoperative weight loss during the first months after gastrectomy for gastric cancer. No significant financial relationships to disclose.


2020 ◽  
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  

BACKGROUND The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). OBJECTIVE This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA<sub>1c</sub> levels. RESULTS A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA<sub>1c</sub> levels (mean difference 0.004%, SE 0.05; <i>P</i>=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; <i>P</i>&lt;.001) and −0.99 kg/m2 (SE 0.29; <i>P</i>=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; <i>P</i>&lt;.001) at 6 months, maintaining 4.7% (SE 0.88; <i>P</i>&lt;.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; <i>P</i>=.85) and gained 0.33% (SE 0.70; <i>P</i>=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA<sub>1c</sub> level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA<sub>1c</sub> levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA<sub>1c</sub> levels. CONCLUSIONS This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. CLINICALTRIAL ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342


2017 ◽  
Vol 4 (2) ◽  
pp. 447 ◽  
Author(s):  
Sukanyaa S. ◽  
Vinoth S. ◽  
Ramesh S.

Background: Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Probiotics are proposed to aid in the quicker colonisation of the preterm gut by various mechanisms thereby providing innumerable health benefits to the preterm infants. Hence we conducted a study to analyse the role of probiotics in preterm babies. Our primary aim was to compare the weight gain pattern among preterm infants: those receiving probiotic and those who did not receive the probiotic.Methods: Preterm/VLBW babies were selected, randomized and placed into two groups. One group was given the chosen probiotic and the other was kept as control. The weight gain pattern and the duration of hospital stay among the two groups was compared at the end of one month of age.Results: The average weight gain in the probiotic group was higher than the control group which was statistically significant. (mean difference: 0.230 + 0.11 95% CI: -0.796 to -0.251 p value <0.000).Conclusions: Our study was yet another evidence proving the utility of probiotics in the field of neonatalogy.


2019 ◽  
Author(s):  
Barbel Knauper ◽  
huma shireen ◽  
Kimberly Carriere ◽  
Mallory Frayn ◽  
Elena Ivanova ◽  
...  

Abstract Background: The NIH-developed Diabetes Prevention Program (DPP) is successful in achieving clinically significant weight loss in individuals with overweight/obesity when delivered one-on-one. However, due to high cost of implementation, the long-term effectiveness remains limited. In response, a group-based version of the program, called the National DPP, was developed. The average weight loss following participation in this program was only about 3.5% with low long-term weight loss maintenance. Purpose: We aimed to optimize weight loss outcomes of the National DPP by integrating the habit formation tool of if-then plans into the program. Results at 3 and 12 months of participation showed no between-group differences between standard and enhanced DPP but higher weight loss in both groups compared to the National DPP. This paper reports the long-term weight loss maintenance data following participation in the program. Methods: Of the 172 participants enrolled at the beginning of the study, data from 110 participants was available and analyzed at 24 months, i.e. 12 months following the end of the 12-month intervention. Results: No between-group difference in weight loss maintenance was seen. Pooled results showed a significant weight regain from 12 to 24 months, i.e. an average of 7.85lbs of the 20.36lbs lost. However, participants from both groups were still 12.51lbs or 6.13% lighter at 24 months than at baseline. Conclusion: If-then plans did not result in a higher percentage of weight loss at 24-month follow-up. However, at 24 months, both groups maintained a significant portion of the weight lost at the end of intervention.


10.2196/17842 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e17842
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  

Background The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). Objective This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. Methods Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. Results A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. Conclusions This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. Trial Registration ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342


2019 ◽  
Author(s):  
Simon Driver ◽  
Chad Swank ◽  
Katherine Froehlich-Grobe ◽  
Evan McShan ◽  
Stephanie Calhoun ◽  
...  

BACKGROUND Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). OBJECTIVE This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. METHODS This RCT will enroll and randomize 64 patients over an 18-month period. RESULTS Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. CONCLUSIONS It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. CLINICALTRIAL ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14338


10.2196/15448 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15448
Author(s):  
Emily Staite ◽  
Adam Bayley ◽  
Ebaa Al-Ozairi ◽  
Kurtis Stewart ◽  
David Hopkins ◽  
...  

Background Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Sai Krupa Das ◽  
Taylor Vail ◽  
Rachel Silver ◽  
Meghan Chin ◽  
Caroline Blanchard ◽  
...  

Abstract Objectives To evaluate the effectiveness of a novel low-burden behavioral intervention (BI) for weight loss on changes in body weight and cardiometabolic risk factors when implemented with or without meal replacements (MR). Methods Twelve worksites (≥300 employees each) in the Greater Boston area participated in a cluster-randomized controlled trial, with 8 worksites (n = 259 participants) allocated to the intervention group (IG) and 4 worksites (n = 76) to a wait-listed control group (CG). IG participants were further randomized to receive the BI, which emphasizes hunger and craving management via diet composition, for 18 months without or with MR (BI + MR). Weight and cardiometabolic variables were measured at baseline and 6 months for all groups, and also at 12 and 18 months in the IGs. Linear mixed models compared 6-month changes in % weight loss, body mass index (BMI), body fat, and cardiometabolic risk factors for all groups. Similar analyses were conducted for the BI and BI + MR groups at 12 and 18 months. Estimated means and standard deviations were calculated. Statistical models were adjusted for age, sex, baseline measurement, and worksite. Results The study population was 83% female. The Mean ± SD for age and BMI were 47.9 ± 10.4 years and 32.9 ± 5.5 kg/m2, respectively. At 6 months, average weight loss was 9.2 ± 7.2% for BI and 8.3 ± 7.0% for BI + MR. Weight loss was significantly greater in both IGs than the CG (both P < 0.001), but not significant between IGs (P = 0.35). Similar results were observed for BMI and % body fat (both P < 0.01). BI and BI + MR had significant reductions in glucose and triglycerides (P < 0.05) compared to the CG. Changes in total cholesterol and LDL were significantly greater in BI + MR compared to BI alone (P < 0.05). Clinically significant reductions in weight and cardiometabolic risk factors were sustained in the IGs at 12 and 18 months. Conclusions To our knowledge, weight loss in this study was greater than previous scalable worksite-based interventions. Weight loss did not significantly differ between the BI and BI + MR groups, and MR use was associated with additional reductions in total and LDL cholesterol. These results demonstrate the feasibility of novel approaches to achieve clinically impactful weight management in worksite settings. Funding Sources Nutrient Foods LLC.


10.2196/14338 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e14338
Author(s):  
Simon Driver ◽  
Chad Swank ◽  
Katherine Froehlich-Grobe ◽  
Evan McShan ◽  
Stephanie Calhoun ◽  
...  

Background Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). Objective This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. Methods This RCT will enroll and randomize 64 patients over an 18-month period. Results Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. Conclusions It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. Clinical Trial ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467


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