Engaging Men From Blue-collar Industries in Weight Loss

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05386238
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Standard behavioral weight loss program; Behavioral: Tailored behavioral weight loss program	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tailored treatment 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.	Behavioral: Tailored behavioral weight loss program; 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.
Active Comparator: Standard of care treatment 6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.	Behavioral: Standard behavioral weight loss program; 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.

Outcome Measures

Primary Outcome Measures

1. Participant satisfaction with the intervention [3 months]

   Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale

2. Recruitment response [Baseline]

   Proportion of participants who enroll in study by recruitment message type

Secondary Outcome Measures

1. Retention rates for each intervention group [6 months]

   Proportion of participants who complete the final follow up assessment

2. Recruitment reach [Baseline]

   Number of visits to study websites

3. Participant satisfaction with the intervention [6 months]

   Acceptability of the intervention will be reported as participants satisfaction with the program rated on a 7 point scale

Other Outcome Measures

1. Clinically significant weight loss [Baseline, 3, and 6 months]

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

2. Program perceptions [3 and 6 months]

   Semi-structured interviews to evaluate participants perceptions of program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

1. Age 18 years and older

2. Male

3. Body mass index (BMI) > 25 kg/m2

4. Employed >20 hours per week in an occupation classified as blue collar

5. Ability to communicate in English

6. Provision of signed and dated informed consent form

Exclusion criteria:

1. History of bariatric surgery

2. Diabetes managed with insulin

3. Diagnosis of a serious mental illness

4. Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire)

5. Report of potentially hazardous alcohol use (ASSIST >27)

6. Weight loss in the prior six months of 10 pounds or greater

7. Body mass index ≥60 kg/m2, due to increased injury risk with exercise

8. Diagnosis of an eating disorder

9. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melissa M. Crane, PhD, Assistant Professor, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT05386238
• Other Study ID Numbers: 18013105-IRB01
• First Posted: May 23, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Melissa M. Crane, PhD, Assistant Professor, Rush University Medical Center: occupation; Behavioral treatment
• Additional relevant MeSH terms: Weight Loss

Study Results

No Results Posted as of Jul 8, 2022