ObesityNCT05386238
Engaging Men From Blue-collar Industries in Weight Loss
A study testing Standard behavioral weight loss program and Tailored behavioral weight loss program in people with Obesity, run by Rush University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard behavioral weight loss program and Tailored behavioral weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Standard behavioral weight loss program, Tailored behavioral weight loss program
- Keywords
- occupation, Behavioral treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard behavioral weight loss programBehavioural
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored treatment | Experimental | 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. Receives: 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. Receives: Behavioral: Standard behavioral weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 6 months
Recruitment Response
The proportion of participants who enroll in the study by recruitment message type.
Measured: Baseline
Secondary outcomes (2)
Retention Rates for Each Intervention Group
Proportion of participants who complete the final follow up assessment
Measured: 6 months
Recruitment Reach
Number of visits to study websites
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start28 Sep 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa M. Crane, PhD, Rush University Medical Center
- Investigators
- Melissa M Crane, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386238
- Sponsor's protocol ID
- 18013105-IRB01
- Status last verified
- Feb 2025
- First submitted
- 12 May 2022
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40918631
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments
- ClinicalTrials.gov ID
- NCT05386238
- Acronym / sponsor ID
- 18013105-IRB01
- Conditions
- Obesity
- Keywords
- occupation, Behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored treatment | Experimental | Behavioral: Tailored behavioral weight loss program6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. |
| Standard of care treatment | Active comparator | Behavioral: Standard behavioral weight loss program6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard behavioral weight loss program16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring. | Behavioural | Standard of care treatment |
| Tailored behavioral weight loss program16 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. | Behavioural | Tailored treatment |
Primary outcome
Participant Satisfaction With the Intervention
Time frame: 6 months
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?"
Recruitment Response
Time frame: Baseline
The proportion of participants who enroll in the study by recruitment message type.
2 secondary outcomes
Retention Rates for Each Intervention Group
Time frame: 6 months
Recruitment Reach
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40918631Crane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa M Crane, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard behavioral weight loss program and Tailored behavioral weight loss program in people with Obesity, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction With the Intervention (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.