NCT05386238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

May 12, 2022

Results QC Date

November 7, 2024

Last Update Submit

February 25, 2025

Conditions

Keywords

occupationBehavioral treatment

Outcome Measures

Primary Outcomes (2)

  • Participant Satisfaction With the Intervention

    Acceptability of the intervention will be reported as participants' satisfaction with the program rated on a 4-point scale. "How satisfied are you overall with the weight management program you received from the Study?"

    6 months

  • Recruitment Response

    The proportion of participants who enroll in the study by recruitment message type.

    Baseline

Secondary Outcomes (2)

  • Retention Rates for Each Intervention Group

    6 months

  • Recruitment Reach

    Baseline

Other Outcomes (2)

  • Clinically Significant Weight Loss

    6 months

  • Program Perceptions

    6 months

Study Arms (2)

Tailored treatment

EXPERIMENTAL

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

Behavioral: Tailored behavioral weight loss program

Standard of care treatment

ACTIVE COMPARATOR

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

Behavioral: Standard behavioral weight loss program

Interventions

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.

Standard of care treatment

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.

Tailored treatment

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIdentify as male
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Male
  • Body mass index (BMI) \> 25 kg/m2
  • Employed \>20 hours per week in an occupation classified as blue collar
  • Ability to communicate in English
  • Provision of signed and dated informed consent form

You may not qualify if:

  • History of bariatric surgery
  • Diabetes managed with insulin
  • Diagnosis of a serious mental illness
  • Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire)
  • Report of potentially hazardous alcohol use (ASSIST \>27)
  • Weight loss in the prior six months of 10 pounds or greater
  • Body mass index ≥60 kg/m2, due to increased injury risk with exercise
  • Diagnosis of an eating disorder
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Melissa Crane
Organization
Rush University Medical Center

Study Officials

  • Melissa M Crane, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 23, 2022

Study Start

September 28, 2022

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

March 18, 2025

Results First Posted

March 18, 2025

Record last verified: 2025-02

Locations