Obesity
Conditions
Keywords
occupation, Behavioral treatment
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALTailored 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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With the Intervention | 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 | Baseline | The proportion of participants who enroll in the study by recruitment message type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rates for Each Intervention Group | 6 months | Proportion of participants who complete the final follow up assessment |
| Recruitment Reach | Baseline | Number of visits to study websites |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Weight Loss | 6 months | Proportion of participants who achieve a weight loss \>5% of initial weight |
| Program Perceptions | 6 months | Semi-structured interviews to evaluate participants perceptions of program |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Tailored Treatment | Standard of Care Treatment | Total |
|---|---|---|---|
| Age, Continuous | 44.5 years | 44 years | 44 years |
| BMI (kg/m2) | 31.6 kg/m2 | 33.4 kg/m2 | 31.8 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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?
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tailored Treatment | Participant Satisfaction With the Intervention | Very Dissatisfied | 2 Participants |
| Tailored Treatment | Participant Satisfaction With the Intervention | Dissatisfied | 0 Participants |
| Tailored Treatment | Participant Satisfaction With the Intervention | Somewhat Satisfied | 3 Participants |
| Tailored Treatment | Participant Satisfaction With the Intervention | Very Satisfied | 7 Participants |
| Standard of Care Treatment | Participant Satisfaction With the Intervention | Very Satisfied | 8 Participants |
| Standard of Care Treatment | Participant Satisfaction With the Intervention | Very Dissatisfied | 1 Participants |
| Standard of Care Treatment | Participant Satisfaction With the Intervention | Somewhat Satisfied | 2 Participants |
| Standard of Care Treatment | Participant Satisfaction With the Intervention | Dissatisfied | 0 Participants |
Primary
Recruitment Response
The proportion of participants who enroll in the study by recruitment message type.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Treatment | Recruitment Response | 3 Participants |
| Standard of Care Treatment | Recruitment Response | 1 Participants |
| Endorsement | Recruitment Response | 3 Participants |
| Combined | Recruitment Response | 0 Participants |
Secondary
Recruitment Reach
Number of visits to study websites
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Treatment | Recruitment Reach | 34 Participants |
| Standard of Care Treatment | Recruitment Reach | 14 Participants |
| Endorsement | Recruitment Reach | 17 Participants |
| Combined | Recruitment Reach | 9 Participants |
Secondary
Retention Rates for Each Intervention Group
Proportion of participants who complete the final follow up assessment
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Treatment | Retention Rates for Each Intervention Group | 11 Participants |
| Standard of Care Treatment | Retention Rates for Each Intervention Group | 11 Participants |
Other Pre-specified
Clinically Significant Weight Loss
Proportion of participants who achieve a weight loss \>5% of initial weight
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Treatment | Clinically Significant Weight Loss | 4 Participants |
| Standard of Care Treatment | Clinically Significant Weight Loss | 4 Participants |
Other Pre-specified
Program Perceptions
Semi-structured interviews to evaluate participants perceptions of program
Time frame: 6 months