Engaging Men From Blue-collar Industries in Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386238
• Other study ID #: 18013105-IRB01
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinically significant weight loss	Proportion of participants who achieve a weight loss >5% of initial weight	Baseline, 3, and 6 months
Other	Program perceptions	Semi-structured interviews to evaluate participants perceptions of program	3 and 6 months
Primary	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
Primary	Recruitment response	Proportion of participants who enroll in study by recruitment message type	Baseline
Secondary	Retention rates for each intervention group	Proportion of participants who complete the final follow up assessment	6 months
Secondary	Recruitment reach	Number of visits to study websites	Baseline
Secondary	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