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Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

ABSTRACT: Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Partnering with a large healthcare system and affiliated university, this project will test an innovative multi-level intervention ("Working for You") adapted from existing group- and individual-level intervention models to promote healthy weight among low-wage workers. The individual-level component is an interactive obesity treatment approach (iOTA) program that involves assessment of behavior risks, collaborative goal-setting with a health coach, and interactive SMS text-messages for ongoing support and self-monitoring. This mHealth intervention is embedded in the group-level component, a workplace participatory program that involves worker teams engaged in the design and implementation of interventions to change their workplace environments. These nested interventions are being tested in a group-randomized trial among 22 work groups (~1000 total workers, ~300 workers with obesity). The primary outcome will be program effects on weight at 2-year follow-up, compared to control, and the secondary outcomes will be effects on diet and physical activity; iOTA adherence, process measures, and work environment/support will also be examined. This pragmatic clinical trial will test scalable interventions that can be translated to other work settings to reduce obesity and related health risks among low-SES workers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02934113.

SUBMITTER: Stein RI

PROVIDER: S-EPMC6521952 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

Stein Richard I RI Strickland Jaime R JR Tabak Rachel G RG Dale Ann Marie AM Colditz Graham A GA Evanoff Bradley A BA

Contemporary clinical trials 20190119

Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Partnering with a large healthcare sys ...[more]

PMID: 30664943

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Project description:BackgroundThere are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity.MethodsWe did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836.FindingsBetween July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed.InterpretationThe MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities.FundingUS National Institutes of Health.

Project description:BACKGROUND:Describing how and why an evidence-based intervention is adapted for a new population and setting using a formal evaluation and an adaptation framework can inform others seeking to modify evidence-based weight management interventions for different populations or settings. The Working for You intervention was adapted, to fit a workplace environment, from Be Fit Be Well, an evidence-based intervention that targets weight-control and hypertension in patients at an outpatient clinic. Workplace-based efforts that promote diet and activity behavior change among low-income employees have potential to address the obesity epidemic. This paper aims to explicitly describe how Be Fit Be Well was adapted for this new setting and population. METHODS:To describe and understand the worksite culture, environment, and policies that support or constrain healthy eating and activity in the target population, we used qualitative and quantitative methods including key informant interviews, focus groups, and a worker survey; these data informed intervention adaptation. We organized the adaptations made to Be Fit Be Well using an adaptation framework from implementation science. RESULTS:The adapted intervention, Working for You, maintains the theoretical premise and evidence-base underpinning Be Fit Be Well. However, it was modified in terms of the means of delivery (i.e., rather than using interactive voice response, Working for You employs automated SMS text messaging), defined as a modification to context by the adaptation framework. The adaptation framework also includes modifications to content; in this case the behavioral goals were modified for the target population based on updated science related to weight loss and to target a workplace population (e.g., a goal to avoiding free food at work). CONCLUSIONS:If effective, this scalable and relatively inexpensive intervention can be translated to other work settings to reduce obesity and diabetes risk among low-SES workers, a group with a higher prevalence of these conditions. Using a formal evaluation and framework to guide and organize how and why an evidence-based intervention is adapted for a new population and setting can push the field of intervention research forward. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02934113 ; Received: October 12, 2016; Updated: November 7, 2017.

Project description:BACKGROUND:Nationwide, emergency response systems depend on 9-1-1 telecommunicators to prioritize, triage, and dispatch assistance to those in distress. 9-1-1 call center telecommunicators (TCs) are challenged by acute and chronic workplace stressors: tense interactions with citizen callers in crisis; overtime; shift-work; ever-changing technologies; and negative work culture, including co-worker conflict. This workforce is also subject to routine exposures to secondary traumatization while handling calls involving emergency situations and while making time urgent, high stake decisions over the phone. Our study aims to test the effectiveness of a multi-part intervention to reduce stress in 9-1-1 TCs through an online mindfulness training and a toolkit containing workplace stressor reduction resources. METHODS/DESIGN:The study employs a randomized controlled trial design with three data collection points. The multi-part intervention includes an individual-level online mindfulness training and a call center-level organizational stress reduction toolkit. 160 TCs will be recruited from 9-1-1 call centers, complete a baseline survey at enrollment, and are randomly assigned to an intervention or a control group. Intervention group participants will start a 7-week online mindfulness training developed in-house and tailored to 9-1-1 TCs and their call center environment; control participants will be "waitlisted" and start the training after the study period ends. Following the intervention group's completion of the mindfulness training, all participants complete a second survey. Next, the online toolkit with call-center wide stress reduction resources is made available to managers of all participating call centers. After 3 months, a third survey will be completed by all participants. The primary outcome is 9-1-1 TCs' self-reported symptoms of stress at three time points as measured by the C-SOSI (Calgary Symptoms of Stress Inventory). Secondary outcomes will include: perceptions of social work environment (measured by metrics of social support and network conflict); mindfulness; and perceptions of social work environment and mindfulness as mediators of stress reduction. DISCUSSION:This study will evaluate the effectiveness of an online mindfulness training and call center-wide stress reduction toolkit in reducing self-reported stress in 9-1-1 TCs. The results of this study will add to the growing body of research on worksite stress reduction programs. TRIAL REGISTRATION:ClinicalTrials.gov Registration Number: NCT02961621 Registered on November 7, 2016 (retrospectively registered).

Project description:Background:Obesity (BMI ?30) during pregnancy is becoming an increasing public health issue and is associated with adverse maternal and perinatal outcomes. Excessive gestational weight gain (GWG) further increases the risks of adverse outcomes. However, lifestyle intervention can help pregnant women with obesity to limit their GWG. This study evaluated whether an antenatal lifestyle intervention programme for pregnant women with obesity, with emphasis on nutrition and physical activity, could influence GWG and maternal and perinatal outcomes. Methods:The intervention was performed in a city in Sweden 2011-2013. The study population was women with BMI ?30 in early pregnancy who received standard antenatal care and were followed until postpartum check-up. The intervention group (n?=?459) was provided with additional support for a healthier lifestyle, including motivational talks with the midwife, food advice, prescriptions of physical activity, walking poles, pedometers, and dietician consultation. The control group was recruited from the same (n?=?105) and from a nearby antenatal organisation (n?=?790). Results:In the per-protocol population, the intervention group had significantly lower GWG compared with the control group (8.9?±?6.0 kg vs 11.2?±?6.9 kg; p?=?0.031). The women managed to achieve GWG <?7 kg to a greater extent (37.1% vs. 23.0%; p?=?0.036) and also had a significantly lower weight retention at the postpartum check-up (-?0.3?±?6.0 kg vs. 1.6?±?6.5 kg; p?=?0.019) compared to the first visit. The most commonly used components of the intervention, apart from the extra midwife time, were support from the dietician and retrieval of pedometers. Overall compliance with study procedures, actual numbers of visits with logbook activity, and dietician contact correlated significantly with GWG. There was no statistically significant difference in GWG (10.3?±?6.1 kg vs. 11.2?±?6.9 kg) between the intervention and control groups in the intention-to-treat population. Conclusion:Pregnant women with obesity who follow a lifestyle intervention programme in primary health care can limit their weight gain during pregnancy and show less weight retention after pregnancy. This modest intervention can easily be implemented in a primary care setting. Trial registration:The study has been registered at ClinicalTrials.gov, Identifier: NCT03147079. May 10 2017, retrospectively registered.

Project description:Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care.Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions.As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have incorporated stakeholder input and tailored components of the interventions to meet the specific needs of the involved clinics and communities. Results from this study will provide knowledge about how integrated multi-level interventions can improve hypertension care and reduce disparities.ClinicalTrials.gov NCT01566864.

Project description:ImportanceGenome-wide association studies have identified genetic loci influencing obesity risk in children. However, the importance of these loci in the associations with weight reduction through lifestyle interventions has not been investigated in large intervention trials.ObjectiveTo evaluate the associations between various obesity susceptibility loci and changes in body weight in children during an in-hospital, lifestyle intervention program.Design, setting, and participantsLong-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children (LOGIC), an interventional prospective cohort study, enrolled 1429 children with overweight or obesity to participate in an in-hospital lifestyle intervention program. Genotyping of 56 validated obesity single-nucleotide variants (SNVs) was performed, and the associations between the SNVs and body weight reduction during the intervention were evaluated using linear mixed-effects models for each SNV. The LOGIC study was conducted from January 6, 2006, to October 19, 2013; data analysis was performed from July 15, 2015, to November 6, 2016.ExposuresA 4- to 6-week standardized in-hospital lifestyle intervention program (daily physical activity, calorie-restricted diet, and behavioral therapy).Main outcomes and measuresThe association between 56 obesity-relevant SNVs and changes in body weight and body mass index.ResultsOf 1429 individuals enrolled in the LOGIC Study, 1198 individuals (mean [SD] age, 14.0 [2.2] years; 670 [56%] girls) were genotyped. A mean (SD) decrease was noted in body weight of -8.7 (3.6) kg (95% CI, -15.7 to -1.8 kg), and body mass index (calculated as weight in kilograms divided by height in meters squared) decreased by -3.3 (1.1) (95% CI, -5.4 to -1.1) (both P < .05). Five of 56 obesity SNVs were statistically significantly associated with a reduction of body weight or body mass index (all P < 8.93 × 10-4 corresponding to Bonferroni correction for 56 tests). Compared with homozygous participants without the risk allele, homozygous carriers of the rs7164727 (LOC100287559: 0.42 kg; 95% CI, 0.31-0.53 kg, P = 4.00 × 10-4) and rs12940622 (RPTOR: 0.35 kg; 95% CI, 0.18-0.52 kg; P = 1.86 × 10-5) risk alleles had a lower reduction of body weight, whereas carriers of the rs13201877 (IFNGR1: 0.65 kg; 95% CI, 0.51-0.79 kg; P = 2.39 × 10-5), rs10733682 (LMX1B: 0.45 kg; 95% CI, 0.27-0.63 kg; P = 6.37 × 10-4), and rs2836754 (ETS2: 0.56 kg; 95% CI, 0.38-0.74 kg; P = 1.51 × 10-4) risk alleles were associated with a greater reduction of body weight after adjustment for age and sex.Conclusions and relevanceGenes appear to play a minor role in weight reduction by lifestyle in children with overweight or obesity. The findings suggest that environmental, social, and behavioral factors are more important to consider in obesity treatment strategies.

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Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

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Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

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