Engaging Men From Blue-collar Industries in Weight Loss

Study Overview
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Brief Summary
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Objectives*: Primary Objective: Aim 1: Examine the acceptability of tailored behavioral weight loss program and a standard program in men working in blue-collar occupations. Aim 2: Compare recruitment approaches that vary on trust-based messaging to recruit men with overweight/obesity who work in blue-collar occupations. Secondary Objectives: Determine the feasibility of retaining participants to a randomized trial over six months.

Detailed Description
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Men working in blue-collar occupations have a high prevalence of overweight and obesity and have high rates of comorbidities associated with obesity. Unfortunately, these men are unlikely to participate in evidenced-based weight loss interventions. Further, few efficacious interventions have been developed that target this population for weight control. The purpose of this study is to test the feasibility and acceptability of tailored recruitment messages and a novel, tailored behavioral weight loss intervention in the context of a randomized trial.

Official Title
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Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard behavioral weight loss program
* Behavioral: Tailored behavioral weight loss program


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18 years and older Male Body mass index (BMI) > 25 kg/m2 Employed >20 hours per week in an occupation classified as blue collar Ability to communicate in English Provision of signed and dated informed consent form Exclusion criteria: History of bariatric surgery Diabetes managed with insulin Diagnosis of a serious mental illness Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire) Report of potentially hazardous alcohol use (ASSIST >27) Weight loss in the prior six months of 10 pounds or greater Body mass index ≥60 kg/m2, due to increased injury risk with exercise Diagnosis of an eating disorder Any major medical condition that could increase risk for injury or other contradictions for treatment, or high likelihood of attrition, as determined by the study team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored treatment<br>6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. | Behavioral: Tailored behavioral weight loss program<br>* 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.<br>|
| Active Comparator: Standard of care treatment<br>6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. | Behavioral: Standard behavioral weight loss program<br>* 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with the intervention | Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale | 3 months | 
| Recruitment response | Proportion of participants who enroll in study by recruitment message type | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rates for each intervention group | Proportion of participants who complete the final follow up assessment | 6 months | 
| Recruitment reach | Number of visits to study websites | Baseline | 
| Participant satisfaction with the intervention | Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occupation, Behavioral treatment