The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention.
Ontology highlight
ABSTRACT: Background
Obesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss.Objective
The aim of the remotely conducted EVO trial is to test the non-inferiority of EVO against DPP. We will conduct economic evaluations alongside the trial to estimate delivery and patient costs, cost-effectiveness, and lifetime healthcare costs of EVO as compared to DPP. Exploratory analyses will examine maintenance, moderators, and mediators of the treatment effect.Study design
The EVO trial will recruit nationally to randomize 524 participants with obesity. Participants will receive either EVO or DPP over a 6 month period. EVO participants will be provided online lessons, a smartphone application to self-monitor diet, physical activity, and weight, and attend 12 brief calls with a Health Promotionist. DPP participants will receive the first 6 months of the Center for Disease Control's T2D materials and attend 16 one-hour video call sessions with staff certified in DPP delivery. Weight will be measured at baseline, 3-, 6-, and 12-months. Itemized delivery cost will be collected. Staff and participants will also provide information to estimate costs for intervention-related activities.Significance
The EVO trial could establish evidence supporting dissemination of a scalable, cost-effective behavioral treatment with potential to shift clinical practice guidelines, inform policy, and reduce the prevalence of obesity.
SUBMITTER: Pfammatter AF
PROVIDER: S-EPMC9133162 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
Publications
The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention.
Pfammatter Angela Fidler AF Battalio Samuel L SL Olvera Charlie C DeZelar Margaret M Moore Dominique D Scanlan Laura L Siddique Juned J Spring Bonnie B Chang Su-Hsin SH
Contemporary clinical trials 20220401
<h4>Background</h4>Obesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss.<h4>Objective</h4>The aim of the remotely conducted EVO trial is to t ...[more]
Similar Datasets
Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n = 60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n = 1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.
| S-EPMC3842709 | biostudies-literature
Project description:BackgroundExcessive gestational weight gain (GWG) is common and can result in maternal and child health complications. Pragmatic behavioral interventions that can be incorporated into standard obstetric care are needed, and financial incentives are a promising approach.ObjectiveThe aim of this study is to evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, in a behavioral program. The program provided small incentives for meeting behavioral goals of self-weighing and physical activity as well as larger outcome incentives for meeting GWG goals.MethodsWe recruited 40 adult women in their first trimester of pregnancy from February 2019 to September 2019 at an obstetric clinic. Participants were randomized to 3 intervention components using a 2×2×2 factorial design: daily incentives for self-weighing (lottery vs certain loss), incentives for adhering to the Institute of Medicine's GWG guidelines based on BMI category (monthly vs overall), and incentives for reaching physical activity goals (yes vs no). Participants were asked to complete daily weigh-ins using the Withings Body wireless scale provided by the study, as well as wear a physical activity tracker (Fitbit Flex 2). Feasibility outcomes of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, were assessed. Weight assessments were conducted at baseline, 32-week gestation, and 36-week gestation.ResultsParticipants were enrolled at, on average, 9.6 (SD 1.8) weeks' gestation. Of the 39 participants who were oriented to their condition and received the intervention, 24 (62%) were Black or African American, 30 (77%) were not married, and 29 (74%) had an annual household income of less than US $50,000. Of the 39 participants, 35 (90%) completed the follow-up data collection visit. Participants were generally quite positive about the intervention components, with a particular emphasis on the helpfulness of, and the enjoyment of using, the e-scale in both the quantitative and qualitative feedback. Participants who received the loss incentive, on average, had 2.86 times as many days of self-weighing as those who received the lottery incentive. Participants had a relatively low level of activity, with no difference between those who received a physical activity incentive and those who did not.ConclusionsA financial incentive-based pragmatic intervention was feasible and acceptable for pregnant women for promoting self-weighing, physical activity, and healthy GWG. Participants were successfully recruited early in their first trimester of pregnancy and retained for follow-up data collection in the third trimester. Participants demonstrated promising engagement in self-weighing, particularly with loss-based incentives, and reported finding the self-weighing especially helpful. This study supports further investigation of pragmatic, clinic-based financial incentive-based interventions for healthy GWG behaviors.Trial registrationClinicalTrials.gov NCT03834194; https://clinicaltrials.gov/ct2/show/NCT03834194.
| S-EPMC8742213 | biostudies-literature
Project description:BackgroundThe notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles.MethodsThis multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California. Akin to a Multiphase Optimization Strategy (MOST) design evaluating multicomponent behavioral interventions, we will compare the combination of an app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention arms. The primary outcome is mean change in zBMI and %BMIp95 over 18 months. We hypothesize that youth who receive App+Coach will have a greater reduction in body weight over the 18-month study period at a lower cost than standard of care models. Secondary outcomes include adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level. We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.ConclusionsNew and creative approaches are needed to address pediatric obesity. If successful, this RCT may provide an innovative and cost-effective mHealth approach, based on addiction methods, for weight loss among adolescents with overweight and obesity.
| S-EPMC8078064 | biostudies-literature
Project description:It is unclear whether weight management is still effective for pregnant women with excessive weight gain in the second or third trimester in China. This study adopted individualized weight management intervention for pregnant women with abnormal weight gain in the second or third trimester, to analyze the effect of intervention by observing the gestational weight gain and perinatal outcomes. This randomized controlled trial was performed at Aerospace Center Hospital. The obstetrician determined whether the pregnant women gained too much weight in the second or third trimester according to the Institute of Medicine guidelines, and randomly divided the pregnant women who gained too much weight in the second or third trimester into the intervention group or the control group according to the inclusion and exclusion criteria. The pregnant women in the intervention group and in the control group all received routine prenatal examination and diet nutrition education by the doctors in the Department of Obstetrics and Gynecology. The intervention group underwent individualized weight management, including individualized diet, exercise, psychological assessment, cognitive intervention and continuous communication, the whole process is tracked and managed by professional nutritionists. The obstetrician collected the prenatal examination data and pregnancy outcome data of all enrolled pregnant women. The primary outcome measure was weight gain during pregnancy. A generalized linear model and a logistic regression model were used to compare the outcomes between the two groups. In total, 348 pregnant women participated in this study with 203 in the intervention group and 145 in the control group. The whole gestational weight gain in the intervention group (15.8 ± 5.4 Kg) was lower than that in the control group (17.5 ± 3.6 Kg; adjusted β = - 1.644; 95% CI [-2.660--0.627]; P = 0.002). The percent of pregnant women with excessive weight gainbefore delivery was 54.2% (110/203) in the intervention group, which was lower than 69.7% (101/145) in the control group (adjusted RR = 0.468; 95% CI [0.284-0.769] P = 0.003). The pregnant women given the individualized weight management intervention from the second to the third trimester experienced less weight gain than that from the third trimester (15.5 ± 5.6 Kg vs. 16.2 ± 5.2 Kg), but without significant difference (P = 0.338). Lower rates of GDM, preeclampsia and gestational hypertension, higher rates of fetal distress and puerperal infection were observed in the intervention group than in the control group (all P < 0.05). Individualized weight management during the second or third trimesters is still beneficial for pregnant women who gain excessive weight and can decrease the associated adverse outcomes.
| S-EPMC8916027 | biostudies-literature
Project description:BackgroundThe financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.Methods/designThe study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).DiscussionPiloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.
| S-EPMC4055289 | biostudies-literature
Project description:BACKGROUND:Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE:The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS:This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS:The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS:This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION:ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).
| S-EPMC5010649 | biostudies-literature
Project description:BackgroundOverweight and obesity are serious public health concerns. As the prevalence of excess weight among individuals continues to increase, there is a parallel need for inexpensive, highly accessible, and evidence-based weight loss programs.ObjectiveThis weight loss trial will aim to examine the efficacy of the Noom weight loss program in comparison to a digital control after a 6-month intervention phase and a 24-month maintenance phase, with assessments continuing for 2 years beyond the intervention (to 30 months-after the baseline). The secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine the severity of obesity-related functional impairment, weight loss history, and demographic moderators, along with adherence and self-efficacy as mediators of the outcome.MethodsA total of 600 participants were randomized in a parallel-group, controlled trial to either Noom Healthy Weight Program (intervention) or Noom Healthy Weight Control (control) for a 6-month intervention. Both intervention and control groups include diet and exercise recommendations, educational content, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes a coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will be conducted at 1, 4, 6, 12, 18, 24, and 30 months after baseline. Weight is measured at each follow-up point during a Zoom call using the participants' scales.ResultsEnrollment began in March 2021 and the 6-month intervention phase ended in March 2022. Data collection for the final assessment will be completed in March 2024.ConclusionsThis study tests commercially available digital lifestyle interventions for individuals with overweight and obesity seeking weight loss support. Data obtained from the study will evaluate whether the Noom Healthy Weight Control Program can help individuals overcome weight loss, achieve long-term maintenance, adhere to lifestyle changes, and feature use barriers that are present in other traditional weight loss treatments.Trial registrationClinicalTrials.gov NCT04797169; https://clinicaltrials.gov/ct2/show/NCT04797169.International registered report identifier (irrid)DERR1-10.2196/37541.
| S-EPMC9419047 | biostudies-literature
Project description:Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy.The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention.This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care.Recruitment has commenced though the recruitment rate is slower than expected. Additional funds are required to employ research assistants and promote the study in an advertising campaign.Feasibility testing highlighted the inadequacy of the original recruitment strategy and the need to provide the app in both major platforms (Android and iOS). Smartphone technologies may offer an effective alternative to resource intensive strategies for assisting women to optimize weight gain in pregnancy.Australian New Zealand Clinical Trials Registry ACTRN12617000169347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371470 (Archived by WebCite at http://www.webcitation.org /6zDvgw5bo).RR1-10.2196/9920.
| S-EPMC6000478 | biostudies-other
Project description:BackgroundOver 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach--SystemCHANGE™--to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal.MethodsWe will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment.DiscussionThis study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors.Trial registrationClinicalTrials.gov Identifier: NCT01776034.
| S-EPMC3663646 | biostudies-literature
Project description:BackgroundWork-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant.ObjectiveThe aim of this study was to assess the cost-effectiveness of a guided iSMI for employees.MethodsA sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000).ResultsWhen the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained.ConclusionsOffering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC.Trial registrationGerman Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749.International registered report identifier (irrid)RR2-10.1186/1471-2458-13-655.
| S-EPMC6707573 | biostudies-literature