Dataset Information

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.

ABSTRACT:

Introduction

Among 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 analysis

We 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 dissemination

The 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 number

NCT03163264; Pre-results.

SUBMITTER: Wittleder S

PROVIDER: S-EPMC7919589 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Wittleder Sandra S Smith Shea S Wang Binhuan B Beasley Jeannette M JM Orstad Stephanie L SL Sweat Victoria V Squires Allison A Wong Laura L Fang Yixin Y Doebrich Paula P Gutnick Damara D Tenner Craig C Sherman Scott E SE Jay Melanie M

BMJ open 20210226 2

<h4>Introduction</h4>Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m<sup>2</sup>) or obese range (≥30 kg/m<sup>2</sup>). 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 ...[more]

PMID: 33637544

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Project description:BackgroundMaternal depression has a recurring course that can influence offspring outcomes. Evidence on how to treat maternal depression to improve longer-term maternal outcomes and reduce intergenerational transmission of psychopathology is scarce, particularly for task-shifted, low-intensity, and scalable psychosocial interventions. We evaluated the effects of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal.Methods40 village clusters in Pakistan were randomly allocated using a computerised randomisation sequence to receive a group-based, psychosocial intervention and enhanced usual care for 36 months, or enhanced usual care alone. Pregnant women (≥18 years) were screened for moderate or severe symptoms of depression (patient health questionnaire-9 [PHQ-9] score ≥10) and were recruited into the trial (570 participants), and a cohort without depression (PHQ-9 score <10) was also enrolled (584 participants). Including the non-depressed dyads enabled us to determine how much of the excess risk due to maternal depression exposure the intervention could mitigate. Research teams responsible for identifying, obtaining consent, and recruiting trial participants were blind to the allocation status throughout the duration of the study, and principal investigators, site coordinators, statisticians, and members of the trial steering committee were also blinded to the allocation status until the analysis of 6-month data for the intervention. Primary outcomes were maternal depression symptoms and remission (PHQ-9 score <10) and child socioemotional skills (strengths and difficulties questionnaire [SDQ-TD]) at 36-months postnatal. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02658994.FindingsFrom Oct 15, 2014 to Feb 25, 2016 46 village clusters were assessed for eligibility, of which 40 (including 1910 mothers were enrolled. After exclusions, 288 women were randomly assigned to the enhanced usual care group and 284 to the intervention group, and 1159 women were included in a group without prenatal depression. At 36-months postnatal, complete data were available from 889 mother-child dyads: 206 (72·5%) in the intervention group, 216 (75·3%) in the enhanced usual care group, and 467 (80·0%) women who did not have prenatal-depression. We did not observe significant outcome differences between the intervention group and the enhanced usual care group for the primary outcomes. The standardised mean difference of PHQ-9 total score was -0·13 (95% CI -0·33 to 0·07), relative risk of patient health questionnaire-9 remission was 1·00 (95% CI 0·88 to 1·14), and the SDQ-TD treatment estimate was -0·10 (95% CI -1·39 to 1·19).InterpretationReduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention. A multi-year, psychosocial intervention can be task-shifted via peers but might be susceptible to reductions in fidelity and dosage over time (which were not among the outcomes of this trial). Early intervention efforts might need to rely on multiple models (eg, collaborative care), be of greater intensity, and potentially targeted at mothers who are at high risk for depression to reduce the intergenerational transmission of psychopathology from mothers to children.FundingNational Institutes of Health.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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.

Similar Datasets

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