scholarly journals Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2673
Author(s):  
Jiun-Ruey Hu ◽  
Hsin-Chieh Yeh ◽  
Noel T. Mueller ◽  
Lawrence J. Appel ◽  
Edgar R. Miller ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cancer Survivors ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Serum Urate ◽  
The Self ◽  
Metformin Treatment ◽  
Behavioral Weight Loss ◽  
Directed Group ◽  
Adult Cancer Survivors

Background: Lower body mass index (BMI) has been associated with lower serum urate (SU), but only in observational studies. We sought to determine the effects of behavioral weight loss and metformin treatment on SU in a randomized trial. Methods and Findings: The Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT) was a parallel three-arm randomized controlled trial of overweight/obese adult cancer survivors without gout at a single center in Maryland, United States. Participants were randomized to: (1) coach-directed weight loss (behavioral telephonic coaching), (2) metformin (up to 2000 mg daily), or (3) self-directed weight loss (informational brochures; reference group). SU and BMI were assessed at baseline and at 3, 6, and 12 months post-randomization. The 121 participants had a mean ± standard deviation (SD) age of 60 ± 9 years, 79% were female, and 45% were Black. At baseline, BMI was 35 ± 5 kg/m2, and SU was 5.6 ± 1.3 mg/dL. Compared to the self-directed group, at 12 months, the coach-directed group reduced BMI by 0.9 kg/m2 (95% confidence interval (CI): −1.5, −0.4) and metformin reduced BMI by 0.6 kg/m2 (95% CI: −1.1, −0.1). However, compared to the self-directed group, the coach-directed group unexpectedly increased SU by 0.3 mg/dL (95% CI: 0.05, 0.6), and metformin non-significantly increased SU by 0.2 mg/dL (95% CI: −0.04, 0.5); these effects were attenuated when analyses included change in estimated glomerular filtration rate (eGFR). Conclusions: In this randomized trial of cancer survivors without gout, reductions in BMI either increased or did not change SU, potentially due to effects on eGFR. These results do not support a focus on BMI reduction for SU reduction; however, long-term studies are needed. ClinicalTrials.gov Registration: NCT02431676.

scholarly journals Changes in Dietary Intake After Metformin Treatment and Behavioral Weight Loss Intervention in Overweight or Obese Cancer Survivors: Results from a Randomized Clinical Trial (P05-029-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Zhongyu Li ◽  
Noel Mueller ◽  
Juraschek Stephen ◽  
Hsin-Chieh Yeh ◽  
Lawrence Appel ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cancer Survivors ◽  
Dietary Fiber ◽  
Food Consumption ◽  
Metformin Treatment ◽  
Weight Loss Intervention ◽  
Behavioral Weight Loss ◽  
Directed Group ◽  
Behavioral Weight Loss Intervention ◽  
Risk Of Cancer

Abstract Objectives Metformin and behavioral weight loss are postulated to lower the risk of cancer development and recurrence in overweight/obese individuals. Few studies have compared dietary changes longitudinally associated with these interventions. This study aimed to investigate the effects of metformin treatment and coach-directed behavioral weight loss intervention on overweight/obese cancer survivors’ food consumption, with an emphasis on fruits, vegetables, fiber, and fat intakes. Methods Overweight and obese cancer survivors enrolled in the SPIRIT trial (n = 121) were randomized into three arms consisting of self-directed weight loss (control), coach-directed weight loss and metformin treatment. Fruit, vegetable and fat screeners were used to assess the diet of the participants at baseline, 3-month, 6-month, and 12-month visit. Linear regression models and Generalized Estimated Equations were performed in STATA 15.1 to analyze the associations between interventions and food consumption throughout the study. Results Groups did not differ by sex (79% female), race (45% black) or age (mean 60 years). Metformin treatment was associated with decreased dietary fiber intake versus self-directed group (difference in slope β = −0.13, 95%CI: −0.01, −0.25; P = 0.04) and versus coach-directed group (−0.130, 95%CI: −0.02, −0.24; P = 0.02). After adjusting for baseline intake, participants assigned to metformin treatment consumed less dietary fiber daily than did participants in the self-directed (−2.0 grams, 95%CI: −0.47, −3.53; P = 0.01) and coach directed groups (−1.54 grams, 95%CI: −0.12, −2.95; P = 0.03) at the 12-month visit. Fruit and vegetable servings also decreased among participants in the metformin group versus non-metformin groups (difference at 12 months = −0.47 servings, 95%CI: 0.00, −0.94; P = 0.05). Coach-directed weight loss reduced % calories from fat compared to self-directed (−1.5% P = 0.03). Conclusions Metformin treatment in overweight/obese cancer survivors was associated with reduced intake of fruits, vegetables, and dietary fiber. The unintended and negative changes of diet that could result in negative impacts on health in metformin users should be noticed in clinical practices and deserve further research. Funding Sources Maryland Cigarette Restitution Funds and SKCCC. Supporting Tables, Images and/or Graphs

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences

2021 ◽  
Author(s):  
Nancy E Sherwood ◽  
A Lauren Crain ◽  
Elisabeth M Seburg ◽  
Meghan L Butryn ◽  
Evan M Forman ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Response Assessment ◽  
Optimal Time ◽  
Behavioral Weight Loss ◽  
Weight Loss Treatment ◽  
Adaptive Intervention ◽  
Weight Losses ◽  
Multiple Assignment

Abstract Background State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30–60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit. Purpose Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT). Method The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months. Results PCM participants lost more weight at 6 months (−18.4 lbs, 95% CI −20.5, −16.2) than ABT participants (−15.7 lbs, 95% CI: −18.0, −13.4), but this difference was not statistically significant (−2.7 lbs, 95% CI: −5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03). Conclusions Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work. Clinical Trial information ClinicalTrials.gov identifier; NCT02368002

Abstract P225: Effect of Weight Loss Strategies on Serum Uric Acid in Cancer Patients in the Spirit Study

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Jiun-ruey Hu ◽  
Hsin-Chieh Yeh ◽  
Noel T Mueller ◽  
Lawrence J Appel ◽  
Edgar R Miller ◽  
...  
Keyword(s):  
Weight Loss ◽  
Uric Acid ◽  
Serum Uric Acid ◽  
Elevated Serum ◽  
The Self ◽  
Weight Loss Intervention ◽  
Long Term Effects ◽  
Intentional Weight Loss ◽  
Directed Group ◽  
Adult Cancer Survivors

Introduction: Obesity is strongly associated with elevated serum uric acid (SUA), a hypothesized mediator of cardiovascular disease. In observational studies, weight loss is associated with lower SUA. However, trial evidence on weight loss and SUA is lacking. Hypothesis: We hypothesized that in a randomized, controlled setting, intentional weight loss would reduce SUA. Methods: The Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT) was a three-arm, parallel trial of overweight or obese adult cancer survivors that compared the effects of a coach-directed weight loss intervention or metformin to self-directed weight loss (ref) on insulin growth factor-1 (IGF-1) over a 1-year period. Participants in the coach-directed arm underwent behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss, targeting a 5% weight loss in the first 6 months. Participants assigned metformin received up to 2,000 mg daily. In our study, SUA was measured in specimens collected at baseline, 3-months, 6-months, and 12-months. Results: There were 121 participants, with a mean age of 60 years (standard deviation [SD]: 9), and a mean body mass index (BMI) of 35 kg/m 2 (SD: 5). Compared to the self-directed group, coach-directed weight loss reduced BMI by 0.6 kg/m 2 (95% CI: 0.1, 1.1) and metformin reduced BMI by 0.9 kg/m 2 (95% CI: 0.4, 1.5) over 12 months. However, compared to the self-directed group, coach-directed weight loss significantly increased SUA by 0.3 mg/dL (95% CI: 0.1, 0.6) over 12 months, while metformin did not significantly affect SUA (0.2 mg/dL; 95% CI: -0.04, 0.5). The increase observed with the coach-directed weight loss intervention occurred primarily within the first 3 months of the intervention (Figure). Conclusions: Contrary to our expectations, intentional weight loss increased SUA in the short-term. These results question weight loss as a strategy for SUA reduction. Studies testing the long-term effects of weight loss on SUA are needed.

Abstract MP16: A Behavioral Weight-loss Intervention, But Not Metformin, Decreases A Marker Of Gut Barrier Permeability In Adult Cancer Survivors With Overweight Or Obesity

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Curtis Tilves ◽  
Hsin-Chieh Yeh ◽  
Nisa Maruthur ◽  
Stephen Juraschek ◽  
Edgar R Miller ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cancer Survivors ◽  
Weight Loss Intervention ◽  
Fiber Intake ◽  
Behavioral Weight Loss ◽  
Gut Permeability ◽  
Gut Barrier ◽  
Adult Cancer Survivors ◽  
Behavioral Weight Loss Intervention ◽  
Overweight Or Obesity

Background: Serum lipopolysaccharide-binding protein (LBP), a surrogate biomarker for gut barrier permeability, is higher in adults with obesity and type 2 diabetes and may trigger inflammation. It is unknown whether a behavioral weight loss intervention or metformin — current first-line treatments for obesity or diabetes — can reduce gut permeability. Objective: To determine the effects of behavioral weight loss intervention or metformin, compared to self-directed weight loss, on serum LBP. Methods: SPIRIT was a parallel-arm, randomized trial of adult cancer survivors with overweight or obesity. Participants were randomized to a self-directed weight loss (control), metformin, or coach-directed (healthy diet/physical activity) weight loss arm. Of 121 randomized participants, a random subset (n=88) had LBP measured at baseline, 6-months, and 12-months post intervention. The effects of interventions on LBP over time were assessed using generalized estimating equations (GEE). Models were further adjusted for absolute change in fiber intake to investigate potential mediation. Results: Arms were balanced by sex (83% female), race (48% black), and age (mean 60 years). There were no between-group differences in LBP at baseline (median 42.3 μg/dL). Over the 12-month period, only the coach-directed and metformin arms showed weight loss (both mean -3% from baseline). Similar increases in LBP were seen in the self-directed and metformin arms, while a decrease in LBP was seen in the coach-directed arm ( figure ). In GEE models, the difference in slopes between the coach vs. self-directed arms was statistically significant (β=-1.67, p=0.037), but not between the metformin and self-directed arms (β=0.003, p=0.997). The effect of coach-directed weight loss on LBP was similar by sex and race and was not mediated by changes in fiber intake. Conclusion: The manner of weight loss can differentially impact gut permeability and thus subsequent exposure to proinflammatory microbial products.

scholarly journals Effects of Behavioral Weight Loss and Metformin on Insulin-like Growth Factors in Cancer Survivors: A Randomized Trial

2021 ◽  
Author(s):  
Hsin-Chieh Yeh ◽  
Nisa M Maruthur ◽  
Nae-Yuh Wang ◽  
Gerald J Jerome ◽  
Arlene T Dalcin ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cancer Survivors ◽  
Mean Difference ◽  
Molar Ratio ◽  
Controlled Clinical Trial ◽  
Behavioral Weight Loss ◽  
Weight Changes ◽  
Trial Duration ◽  
Directed Group ◽  
Increased Risk

Abstract Context Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence. Design Randomized, 3-parallel-arm controlled clinical trial. Interventions and Outcomes Cancer survivors with overweight or obesity were randomized to 1) self-directed weight loss (comparison), 2) coach-directed weight loss, or 3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at six months. The trial duration was 12 months. Results Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average BMI was 35 kg/m 2; mean IGF-1 was 72.9 (SD, 21.7) ng/ml; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (p=0.07), −4.2% (p<0.0001), and -2.8% (p<0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared to the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/ml, p=0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, p=0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/ml; 95% CI: -13.3 to -1.1), but not in participants with overweight (p-for interaction=0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months. Conclusions In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.

scholarly journals Behavioral Weight Loss Intervention for Migraine: A Randomized Controlled Trial

Obesity ◽  
2017 ◽  
Vol 26 (1) ◽  
pp. 81-87 ◽  
Author(s):  
Dale S. Bond ◽  
J. Graham Thomas ◽  
Richard B. Lipton ◽  
Julie Roth ◽  
Jelena M. Pavlovic ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Weight Loss Intervention ◽  
Behavioral Weight Loss ◽  
Randomized Controlled ◽  
Behavioral Weight Loss Intervention
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