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Completed

NCT Number: NCT05386238

Engaging Men From Blue-collar Industries in Weight Loss

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard behavioral weight loss program

Behavioral

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.

Tailored behavioral weight loss program

Behavioral

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.

Primary outcomes

  1. Participant Satisfaction With the Intervention

    Time frame: 6 months

    Acceptability of the intervention will be reported as participants' satisfaction with the program rated on a 4-point scale. "How satisfied are you overall with the weight management program you received from the Study?"

  2. Recruitment Response

    Time frame: Baseline

    The proportion of participants who enroll in the study by recruitment message type.

Secondary outcomes

  1. Retention Rates for Each Intervention Group

    Time frame: 6 months

    Proportion of participants who complete the final follow up assessment

  2. Recruitment Reach

    Time frame: Baseline

    Number of visits to study websites

Other outcomes

  1. Clinically Significant Weight Loss

    Time frame: 6 months

    Proportion of participants who achieve a weight loss >5% of initial weight

  2. Program Perceptions

    Time frame: 6 months

    Semi-structured interviews to evaluate participants perceptions of program

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2022
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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