A Novel Approach to Reducing Adiposity Among Young Men

Study Overview
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Brief Summary
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The purpose of this research study is to find out whether a primarily self-guided program can produce changes in weight, body fat and cardiovascular risk among young men.

Detailed Description
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This self-guided lifestyle intervention may help men to reduce weight and improve heart health because it has been adapted to meet the possible weight loss needs of young men. Young men may experience reductions in body weight after enrollment in the intervention, but this is unknown. Study participation lasts approximately 3 months. Participants will be assessed by the study staff and fill out questionnaires about current lifestyle practices (diet, physical activity, sleep habits, risk behaviors). Weight, medical events, and medication use within the last 3 months will be assessed. Eligible participants will be randomly assigned (like the flip of a coin) to the control group or self-guided group.

Official Title
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A Novel Approach to Reducing Adiposity Among Young Men

Conditions
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Men, Weight Loss, Lifestyle Risk Reduction, Cardiovascular Diseases, Obesity

Intervention / Treatment
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* Behavioral: Self-guided lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-identify as a man 18-35 years old BMI 25-45kg/m2 Live in North America Exclusion Criteria: an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension) a diagnosis of Type 1 or Type 2 diabetes report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery change in medication(s) within the last 3 months that could influence weight (e.g., steroids) have lost > 5% body weight within the last 3 months report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months report hospitalization for a psychiatric condition within the last year report high alcohol intake (AUDIT score > 16). are not able to speak and read English do not possess a mobile device or are unwilling to use it to receive study text messages Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Delayed Treatment Control group<br>Participants will receive the treatment after completion of the 3-month follow-up assessment | |
| Experimental: Lifestyle group<br>Participants will receive the treatment immediately | Behavioral: Self-guided lifestyle intervention<br>* The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks. Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight lost | Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived risk for heart disease | Perceived risk assessed via 12-item Risk Behavior Diagnosis scale | Baseline to 3 months | 
| Change in minutes of moderate to vigorous physical activity | Physical activity assessed via 21-item Global Physical Activity Questionnaire | Baseline to 3 months | 
| Change in diet quality | Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire | Baseline to 3 months | 
| Change in sleep quality | Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire | Baseline to 3 months |