scholarly journals Using Technology to Promote Postpartum Weight Loss in Urban, Low-Income Mothers: A Pilot Randomized Controlled Trial

2014 ◽  
Vol 46 (6) ◽  
pp. 610-615 ◽  
Author(s):  
Sharon J. Herring ◽  
Jane F. Cruice ◽  
Gary G. Bennett ◽  
Adam Davey ◽  
Gary D. Foster
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Postpartum Weight ◽  
Low Income Mothers ◽  
Pilot Randomized Controlled Trial

scholarly journals The ASHA (Hope) Project: Testing an Integrated Depression Treatment and Economic Strengthening Intervention in Rural Bangladesh: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (1) ◽  
pp. 279
Author(s):  
Alison Karasz ◽  
Shabnam Anne ◽  
Jena Derakhshani Hamadani ◽  
Fahmida Tofail
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Cash Transfer ◽  
Depression Treatment ◽  
Rural Bangladesh ◽  
Randomized Controlled ◽  
Low Income Women ◽  
Economic Strengthening ◽  
Pilot Randomized Controlled Trial

Depression, a debilitating disorder, is highly prevalent among low-income women in low- and middle-income countries. Standard psychotherapeutic approaches may be helpful, but low treatment uptake, low retention, and transient treatment effects reduce the benefit of therapy. This pilot randomized controlled trial examined the effectiveness and feasibility of an integrated depression treatment/economic strengthening intervention. The study took place in two villages in the Sirajganj district in rural Bangladesh. Forty-eight low-income women with depressive symptoms (Patient Health Questionnaire (PHQ-9) score ≥ 10) were recruited and randomized to intervention or control arms. The intervention included a six-month group-based, fortnightly depression management and financial literacy intervention, which was followed by a cash-transfer of $186 (equivalent to the cost of two goats) at 12 months’ follow-up. The cash transfer could be used to purchase a productive asset (e.g., agricultural animals). The control arm received no intervention. Findings showed significant reduction in depression scores in the intervention group. The mean PHQ-9 score decreased from 14.5 to 5.5 (B ± SE, −9.2 ± 0.8 95% CI −10.9, −7.5, p < 0.01) compared to no change in the control group. Most other psycho-social outcomes, including tension, self-esteem, hope, social-support, and participation in household economic decision-making, also improved with intervention. An integrated depression treatment and financial empowerment intervention was found to be highly effective among rural low-income women with depression. Next steps involve formal testing of the model in a larger trial.

scholarly journals Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Natalie D Ritchie ◽  
Jodi Summers Holtrop ◽  
R Mark Gritz ◽  
Katherine Ann Sauder ◽  
Michael Josh Durfee ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Evidence Based ◽  
Randomized Controlled

BACKGROUND Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. OBJECTIVE This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. METHODS This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. RESULTS This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. CONCLUSIONS This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. CLINICALTRIAL ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15499

scholarly journals Effects of weight loss on foot structure and function in obese adults: A pilot randomized controlled trial

2015 ◽  
Vol 41 (1) ◽  
pp. 86-92 ◽  
Author(s):  
Jinsup Song ◽  
Reagan Kane ◽  
Dana N. Tango ◽  
Stephanie S. Vander Veur ◽  
James Furmato ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Structure And Function ◽  
Obese Adults ◽  
Randomized Controlled ◽  
Foot Structure ◽  
And Function ◽  
Pilot Randomized Controlled Trial

scholarly journals Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Briana J. Stith ◽  
Samantha M. Buls ◽  
Sarah A. Keim ◽  
Stephen F. Thung ◽  
Mark A. Klebanoff ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Body Composition ◽  
Energy Expenditure ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Daily Activities ◽  
Randomized Controlled ◽  
Postpartum Weight

Abstract Background Up to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postpartum weight loss and contribute to T2DM prevention efforts. However, some women have difficulty prioritizing self-care during this life stage. Efficacious interventions that women can balance with motherhood to reduce T2DM risk remain a goal. The objective of the Moms in Motion study is to evaluate the efficacy of a simple, novel, activity-boosting intervention using ankle weights worn with daily activities during a 6-month postpartum intervention among women with GDM. We hypothesize that women randomized to the 6-month intensity-modifying intervention will (1) demonstrate greater weight loss and (2) greater improvement in body composition and biomarker profile versus controls. Methods This study will be a parallel two-arm randomized controlled trial (n = 160). Women will be allocated 1:1 to an ankle weight intervention group or a standard-of-care control group. The intervention uses ankle weights (1.1 kg) worn on each ankle during routine daily activities (e.g., cleaning, childcare). Primary outcomes include pre- and post-assessments of weight from Visit 2 to Visit 3. Secondary outcomes include body composition, glycemia (2-h, 75 g oral glucose tolerance test), and fasting insulin. Exploratory outcomes include energy expenditure, diet, and psychosocial well-being. Discussion Beyond the expected significance of this study in its direct health impacts from weight loss, it will contribute to exploring (1) the mechanism(s) by which the intervention is successful (mediating effects of energy expenditure and diet on weight loss) and (2) the effects of the intervention on body composition and biomarkers associated with insulin resistance and metabolic health. Additionally, we expect the findings to be meaningful regarding the intervention’s effectiveness on engaging women with GDM in the postpartum period to reduce T2DM risk. Trial registration The ClinicalTrials.gov Identifier, is NCT03664089. The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim.

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