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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored treatment | Experimental | 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. |
|
| Standard of care treatment | Active Comparator | 6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard behavioral weight loss program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rates for Each Intervention Group | Proportion of participants who complete the final follow up assessment | 6 months |
| Recruitment Reach | Number of visits to study websites |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Weight Loss | Proportion of participants who achieve a weight loss >5% of initial weight | 6 months |
| Program Perceptions | Semi-structured interviews to evaluate participants perceptions of program |
Inclusion criteria:
Exclusion criteria:
Identify as male
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| Name | Affiliation | Role |
|---|---|---|
| Melissa M Crane, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40918631 | Derived | 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. |
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All consented participants were randomized into the study. 63 who completed the initial screening were excluded due to not meeting eligibility criteria, 9 were unable to be contacted, and 17 did not complete the study enrollment procedures.
Participants were recruited between September 28, 2022, and March 30, 2023. Recruitment was closed before our planned sample size was recruited to complete the study within the funding period
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Treatment | 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. 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. |
| FG001 | Standard of Care Treatment | 6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Treatment | 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Posted | Count of Participants | Participants | 6 months |
|
Collected at 3 and 6 months assessments systematically and as reported by participants during intervention visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Treatment | 6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Crane | Rush University Medical Center | 312-563-0269 | melissa_m_crane@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2022 | Aug 24, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2022 | Aug 24, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Tailored behavioral weight loss program | 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. |
|
| Baseline |
| 6 months |
| BG001 | Standard of Care Treatment | 6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI (kg/m2) | Median | Inter-Quartile Range | kg/m2 |
|
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. 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. |
|
|
| Primary | Recruitment Response | The proportion of participants who enroll in the study by recruitment message type. | 1000 postcards of each message type were sent to men in the recruitment area. A subset of postcards were returned undelivered and were removed from the analysis. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Retention Rates for Each Intervention Group | Proportion of participants who complete the final follow up assessment | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Recruitment Reach | Number of visits to study websites | 1000 postcards of each message type were sent to men in the recruitment area. A subset of postcards were returned undelivered and were removed from the analysis. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Clinically Significant Weight Loss | Proportion of participants who achieve a weight loss >5% of initial weight | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Program Perceptions | Semi-structured interviews to evaluate participants perceptions of program | Not Posted | 6 months | Participants |
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Standard of Care Treatment | 6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance. 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. | 0 | 14 | 0 | 14 | 3 | 14 |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |