Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study

Wittleder, Sandra; Ajenikoko, Adefunke; Bouwman, Dylaney; Fang, Yixin; McKee, M. Diane; Meißner, Paul; Orstad, Stephanie L.; Rehm, Colin D.; Sherman, Scott E.; Smith, Shea N.; Sweat, Victoria; Velastegui, Lorena; Wylie‐Rosett, Judith; Jay, Melanie

doi:10.1016/j.cct.2019.06.005

Cited by 8 publications

(7 citation statements)

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“…The sample consisted of 483 primary care patients enrolled in this RCT. Study methods for the clinical trial are published in detail elsewhere [ 33 ]. All methods were performed in accordance with the relevant guidelines and regulations approved by the Institutional Review Boards at NYU School of Medicine (#i16–01445), VA NY Harbor (#01624), and Albert Einstein College of Medicine in collaboration with the Montefiore Health System (#2017–7603).…”

Section: Methodsmentioning

confidence: 99%

Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study

et al. 2021

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Background Everyday experiences with racial (RD) and weight discrimination (WD) are risk factors for chronic pain in ethnically diverse adults with obesity. However, the individual or combined effects of RD and WD on pain in adults with obesity is not well understood. There are gender differences and sexual dimorphisms in nociception and pain, but the effect of gender on relationships between RD, WD, and pain outcomes in ethnically diverse adults with obesity is unclear. Thus, the purposes of this study were to: 1) examine whether RD and WD are associated with pain intensity and interference, and 2) explore gender as a moderator of the associations between RD, WD, and pain. Methods This is a baseline data analysis from a randomized, controlled clinical trial of a lifestyle weight-management intervention. Eligible participants were English or Spanish-speaking (ages 18–69 years) and had either a body mass index of ≥30 kg/m2 or ≥ 25 kg/m2 with weight-related comorbidity. RD and WD were measured using questions derived from the Experiences of Discrimination questionnaire (EOD). Pain interference and intensity were measured using the PROMIS 29 adult profile V2.1. Linear regression models were performed to determine the associations between WD, RD, gender, and pain outcomes. Results Participants (n = 483) reported mild pain interference (T-score: 52.65 ± 10.29) and moderate pain intensity (4.23 ± 3.15). RD was more strongly associated with pain interference in women (b = .47, SE = .08, p < 001), compared to men (b = .14, SE = .07, p = .06). Also, there were no significant interaction effects between RD and gender on pain intensity, or between WD and gender on pain interference or pain intensity. Conclusions Pain is highly prevalent in adults with obesity, and is impacted by the frequencies of experiences with RD and WD. Further, discrimination against adults with obesity and chronic pain could exacerbate existing racial disparities in pain and weight management. Asking ethnically diverse adults with obesity about their pain and their experiences of RD and WD could help clinicians make culturally informed assessment and intervention decisions that address barriers to pain relief and weight loss. Trial registration NCT03006328

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Section: Methodsmentioning

confidence: 99%

Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study

et al. 2021

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“…We developed a novel technology-assisted peer coaching intervention, called the Peer-Assisted Lifestyle (PAL) intervention, that uses the 5As (Assess, Advise, Agree, Assist, Arrange) counselling framework 34 and was adapted from our Goals for Eating and Moving (GEM) study. 35 A pilot study of the GEM intervention (n=22) showed modest BM loss when compared with control (n=23) for 6 months (−1.5±3.1 kg vs 0.2± 3.6 kg, p = 0.08). 36 The PAL intervention builds on our experience with GEM, 35 with the added focus on peer coaches to address the specific needs of veterans.…”

Section: Introductionmentioning

confidence: 95%

“… 35 A pilot study of the GEM intervention (n=22) showed modest BM loss when compared with control (n=23) for 6 months (−1.5±3.1 kg vs 0.2± 3.6 kg, p = 0.08). 36 The PAL intervention builds on our experience with GEM, 35 with the added focus on peer coaches to address the specific needs of veterans. The PAL study’s aims are to (1) determine the impact of PAL on BM, clinical and behavioural outcomes; (2) identify predictors of BM loss related to PAL intervention components and goal-setting processes; and (3) evaluate PAL’s impact on PCP obesity-related counselling attitudes and practices.…”

Section: Introductionmentioning

confidence: 95%

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care

et al. 2021

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IntroductionAmong US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m2) or obese range (≥30 kg/m2). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months). Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans. We describe the rationale and design of a cluster-randomised controlled trial to test the efficacy of the Peer-Assisted Lifestyle (PAL) intervention compared with enhanced usual care (EUC) to improve BM loss, clinical and behavioural outcomes (aim 1); identify BM-loss predictors (aim 2); and increase PCP counselling (aim 3).Methods and analysisWe are recruiting 461 veterans aged 18–69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System. To deliver counselling, PAL uses in-person and telephone-based peer support, a tablet-delivered goal-setting tool and PCP training. Patients in the EUC arm receive non-tailored healthy living handouts. In-person data collection occurs at baseline, month 6 and month 12 for patients in both arms. Repeated measures modelling based on mixed models will compare mean BM loss (primary outcome) between study arms.Ethics and disseminationThe protocol has been approved by the Institutional Review Board and the Research and Development Committee at the VA NY Harbor Health Systems (#01607). We will disseminate the results via peer-reviewed publications, conference presentations and meetings with stakeholders.Trial registration numberNCT03163264; Pre-results.

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“…The four MMG practices -Bronx East, Castle Hill, Grand Concourse, and University Avenue-are a liated with the New York City Research and Improvement Networking Group. The trial was registered at clinicaltrials.gov (NCT03006328, December 30,2016). The sample consisted of 483 primary care patients enrolled in this RCT.…”

mentioning

confidence: 99%

“…Study methods for the clinical trial are published in detail elsewhere. (30) All methods were performed in accordance with the relevant guidelines and regulations approved by the Institutional Review Boards at NYU School of Medicine (#i16-01445), VA NY Harbor (#01624), and Albert Einstein College of Medicine in collaboration with the Monte ore Health System (#2017-7603). All patients gave their informed consent to the study before data collection began.…”

mentioning

confidence: 99%

Racial and Weight Discrimination Associations with Pain Intensity and Pain Interference in An Ethnically Diverse Sample of Adults with Obesity: A Baseline Analysis of the Clustered Randomized-Controlled Clinical Trial the Goals for Eating and Moving (GEM) Study

Merriwether

Wittleder

Cho

et al. 2021

Preprint

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Background: Everyday experiences with racial (RD) and weight discrimination (WD) are risk factors for chronic pain in ethnically diverse adults with obesity. However, the individual or combined effects of RD or WD on pain in adults with obesity is not well understood. There are gender differences and sexual dimorphisms in nociception and pain, but the effect of gender on relationships between RD and WD in ethnically diverse adults with obesity has not been examined. The goals of this study were to: 1) examine whether weight and racial discrimination are associated with pain intensity and interference, and 2) explore gender as a moderator of the effects of WD and RD on pain.Methods: This is a baseline data analysis from a randomized controlled weight-management trial. Eligible participants were English or Spanish-speaking (ages 18-69 years) and had either a body mass index of ≥ 30 kg/m2 or ≥ 25 kg/m2 with weight-related comorbidity. WD and RD were measured using the Experiences of Discrimination questionnaire (EOD). Pain outcome (pain interference and intensity) were measured using the PROMIS 29 adult profile V2.1. Linear regression models were performed to determine the associations between WD, RD, and gender, with pain outcomes.Results. On average participants reported mild pain interference (T-score: 52.65±10.29) and moderate pain intensity (4.23±3.15, scale: 0-10). There was a significant interaction effect of RD and gender on pain interference. RD was more strongly associated with pain interference in women (b = .47, SE = .08, p < 001), compared to men (b = .14, SE = .07, p = .06). There were no significant interaction effects between RD and gender on pain intensity, or between WD and gender on pain interference or intensity. Conclusions: Pain is highly prevalent in adults with obesity, and is impacted by experiences of racial and weight discrimination. Further, discrimination against adults with obesity and chronic pain could exacerbate existing racial disparities in pain and weight management. Asking ethnically diverse adults with obesity about their pain and their experiences of racial and weight discrimination could help clinicians make culturally informed decisions that address barriers to pain relief and weight loss.Trial Registration: NCT03006328

show abstract

Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study

Cited by 8 publications

References 43 publications

Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study

Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care

Racial and Weight Discrimination Associations with Pain Intensity and Pain Interference in An Ethnically Diverse Sample of Adults with Obesity: A Baseline Analysis of the Clustered Randomized-Controlled Clinical Trial the Goals for Eating and Moving (GEM) Study

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