Clinical trial NCT05386238: Engaging Men From Blue-collar Industries in Weight Loss
Official title: Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: occupation
Behavioral treatment
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Satisfaction With the Intervention
timeFrame: 6 months
measure: Recruitment Response
timeFrame: Baseline
Secondary outcomes:
measure: Retention Rates for Each Intervention Group
timeFrame: 6 months
measure: Recruitment Reach
timeFrame: Baseline
Other outcomes:
measure: Clinically Significant Weight Loss
timeFrame: 6 months
measure: Program Perceptions
timeFrame: 6 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Melissa M Crane, PhD
role: PRINCIPAL_INVESTIGATOR
References: