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Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial.

ABSTRACT: Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Study participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age???18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI)???27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.clinicaltrials.gov NCT02176915 . Registered 25 June 2014.

SUBMITTER: Rosal MC

PROVIDER: S-EPMC5016872 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial.

Rosal Milagros C MC Haughton Christina F CF Estabrook Barbara B BB Wang Monica L ML Chiriboga Germán G Nguyen Oahn H T OH Person Sharina D SD Lemon Stephenie C SC

BMC public health 20160909

<h4>Background</h4>Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and ...[more]

PMID: 27612615

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Project description:BACKGROUND:Efforts to translate evidence-based weight loss interventions, such as the Diabetes Prevention Program (DPP), to low-income postpartum women have resulted in poor intervention attendance and high attrition. Strategies that improve engagement and retention in this population are needed to maximize the reach of evidence-based weight loss interventions. OBJECTIVE:The objective of this study was to adapt a DPP-based weight loss intervention (Fresh Start) for Facebook delivery and to evaluate its feasibility among low-income postpartum women. METHODS:This study comprised 3 single-group pilot studies where feasibility outcomes iteratively informed changes from one pilot to the next. We paralleled the in-person program for Facebook delivery by translating the protocol to a content library of Facebook posts with additional posts from lifestyle coaches. Low-income postpartum women were recruited from Women, Infants, and Children (WIC) clinics in Worcester, Massachusetts. Participants were enrolled into a 16-week weight loss intervention delivered via Facebook. During the first 8 weeks, Facebook intervention posts were delivered 2 times per day, with additional posts from coaches aiming to stimulate interaction among participants or respond to participants' questions and challenges. For the following 8 weeks, posts were delivered once per day without additional coaching. Feasibility outcomes were engagement (defined by number of likes, comments, and posts measured throughout intervention delivery), acceptability, and retention (survey at follow-up and assessment completion rate, respectively). Changes in weight were also assessed at baseline and follow-up. RESULTS:Pilot 1 had a retention rate of 89% (24/27), and on average, 62% (17/27) of women actively engaged with the group each week during the 8-week coached phase. Mean weight loss was 2.6 (SD 8.64) pounds, and 79% (19/27) would recommend the program to a friend. Pilot 2 had a retention rate of 83% (20/24), and on average, 55% (13/24) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 2.5 (SD 9.23) pounds, and 80% (16/24) would recommend the program to a friend. Pilot 3 had a retention rate of 88% (14/16), and on average, 67% (11/16) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 7.0 (SD 11.6) pounds, and 100% (16/16) would recommend the program to a friend. CONCLUSIONS:Our findings demonstrated that a Facebook-delivered intervention was acceptable and could be feasibly delivered to low-income postpartum women. Future research is needed to evaluate the efficacy of a Facebook-delivered weight loss intervention.

Project description:Introduction: Due to the increasing prevalence of obesity, approaches for a more effective treatment especially in the long-term perspective are needed. However, studies on weight loss and maintenance show heterogeneous results with large inter-individual variations. Therefore, it is of interest to identify factors that contribute to inter-individual differences and predict the success of long-term weight management. Methods and Analysis: The primary outcome of the Lifestyle Intervention (LION) Study is to evaluate the effect of two diets (low carb vs. low fat) and two digital counseling tools (newsletter vs. mobile application) on weight maintenance 12 months after weight loss. The identification of predictive factors (e.g., genetic, epigenetic, physiological, psychological) for the success of weight loss and maintenance is a secondary outcome. Men and women with a body mass index (BMI) between 30.0 and 39.9 kg/m2, aged 18-65 years, and without severe diseases are considered eligible. After phenotyping (e.g., anthropometry, resting metabolic rate, meal challenges, blood parameters) participants will follow a formula-based, low-calorie diet (LCD) for 8 weeks. In addition, the intake of 200 g raw or cooked non-starchy vegetables are allowed per day. Subsequently, 252 participants will be randomized into one of the four intervention groups (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter) for the 12-month weight maintenance step. The study will be concluded after another 12 months of follow-up. Results should provide indications for successful weight management and give insights into the personalized treatment of obesity. Ethics and Dissemination: This study has been granted ethical approval by the local Ethics Review Committee of the School of Medicine, Technical University of Munich (vote: 69/19 S). Trial Registration Number: This study has been registered within ClinicalTrials.gov (NCT04023942) and the German Clinical Trials Register (DRKS00017819).

Project description:ImportancePostpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women.ObjectiveTo test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months.Design, setting, and participantsA 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016.InterventionsClinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics.Main outcomes and measuresThe primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet.ResultsParticipants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P < .001; difference, 2.3 kg (95% CI, 1.1 to 3.5). More participants in the intervention group than the standard care group returned to preconception weight by 12 months (32.8% in the intervention group vs 18.6% in the standard care group, P < .001; difference, 14.2 percentage points [95% CI, 4.7 to 23.5]). The intervention group and standard care group did not significantly differ in 12-month changes in physical activity (mean [95% CI]: -7.8 min/d [-16.1 to 0.4] in the intervention group vs -7.2 min/d [-14.6 to 0.3] in the standard care group; difference, -0.7 min/d [95% CI, -42.0 to 10.6], P = .76), calorie intake (mean [95% CI]: -298 kcal/d [-423 to -174] in the intervention group vs -144 kcal/d [-257 to -32] in the standard care group; difference, -154 kcal/d [-325 to 17], P = .06), or incidences of injury (16 in the intervention group vs 16 in the standard care group) or low breastmilk supply from baseline to month 6 (21 of 61 participants in the intervention group vs 23 of 72 participants in the standard care group) and from month 6 to 12 (13 of 32 participants in the intervention group vs 14 of 37 participants in the standard care group).Conclusions and relevanceAmong low-income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to determine program and cost-effectiveness as part of the WIC program.Trial registrationclinicaltrials.gov Identifier: NCT01408147.

Project description:BackgroundUp 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.MethodsThis 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.DiscussionBeyond 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 registrationThe ClinicalTrials.gov Identifier, is NCT03664089 . The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim.

Project description:BackgroundOverweight and obesity amongst women of reproductive age are increasingly common in developed economies and are shown to adversely affect birth outcomes and both childhood and adulthood health risks in the offspring. Metabolic profiling in conditions of overweight and obesity in pregnancy could potentially be applied to elucidate the molecular basis of the adverse effects of gestational weight gain (GWG) and postpartum weight loss (WL) on future risks for cardiovascular disease (CVD) and other chronic diseases.MethodsBiofluid samples were collected from 114 ethnically diverse pregnant women with body mass index (BMI) between 25 and 40 kg/m2 from Chicago (US), as part of a randomized lifestyle intervention trial (Maternal Offspring Metabolics: Family Intervention Trial; NCT01631747). At 15 weeks, 35 weeks of gestation, and at 1 year postpartum, the blood plasma lipidome and metabolic profile of urine samples were analyzed by liquid chromatography mass spectrometry (LC-MS) and 1H nuclear magnetic resonance spectroscopy (1H NMR) respectively.ResultsUrinary 4-deoxyerythronic acid and 4-deoxythreonic acid were found to be positively correlated to BMI. Seventeen plasma lipids were found to be associated with GWG and 16 lipids were found to be associated with WL, which included phosphatidylinositols (PI), phosphatidylcholines (PC), lysophospholipids (lyso-), sphingomyelins (SM) and ether phosphatidylcholine (PC-O). Three phospholipids found to be positively associated with GWG all contained palmitate side-chains, and amongst the 14 lipids that were negatively associated with GWG, seven were PC-O. Six of eight lipids found to be negatively associated with WL contained an 18:2 fatty acid side-chain.ConclusionsMaternal obesity was associated with characteristic urine and plasma metabolic phenotypes, and phospholipid profile was found to be associated with both GWG and postpartum WL in metabolically healthy pregnant women with overweight/obesity. Postpartum WL may be linked to the reduction in the intake of linoleic acid/conjugated linoleic acid food sources in our study population.

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Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial.

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Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial.

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