Engaging Men From Blue-collar Industries in Weight Loss

NCT ID: NCT05386238

Last Updated: 2025-03-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2023-11-15

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tailored treatment

6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.

Group Type EXPERIMENTAL

Tailored behavioral weight loss program

Intervention Type 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.

Standard of care treatment

6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.

Group Type ACTIVE_COMPARATOR

Standard behavioral weight loss program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Melissa M. Crane, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa M Crane, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Crane MM, Feit C, Yeh C, Ortiz MG, Appelhans BM. Feasibility and Acceptability of Behavioral Weight Loss Programs for Men in Trade and Labor Occupations: A Pilot Study. Obes Sci Pract. 2025 Mar 1;11(2):e70066. doi: 10.1002/osp4.70066. eCollection 2025 Apr.

Reference Type DERIVED
PMID: 40918631 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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18013105-IRB01

Identifier Type: -

Identifier Source: org_study_id

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