Engaging Men From Blue-collar Industries in Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Tailored behavioral weight loss program; Behavioral: Standard behavioral weight loss program

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant weight loss	Proportion of participants who achieve a weight loss >5% of initial weight	Baseline, 3, and 6 months
Program perceptions	Semi-structured interviews to evaluate participants perceptions of program	3 and 6 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Melissa M Crane, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Behavioral treatment; occupation
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 18013105-IRB01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No