A Novel Approach to Reducing Adiposity Among Young Men
- Conditions
- Lifestyle Risk ReductionCardiovascular DiseasesWeight LossObesityMen
- Interventions
- Behavioral: Self-guided lifestyle intervention
- Registration Number
- NCT04267263
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35
- self-identify as a man
- 18-35 years old
- BMI 25-45kg/m2
- Live in North America
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle group Self-guided lifestyle intervention Participants will receive the treatment immediately
- Primary Outcome Measures
Name Time Method Percent weight lost 3 months Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight \*100
- Secondary Outcome Measures
Name Time Method Change in perceived risk for heart disease Baseline to 3 months Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
Change in minutes of moderate to vigorous physical activity Baseline to 3 months Physical activity assessed via 21-item Global Physical Activity Questionnaire
Change in diet quality Baseline to 3 months Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
Change in sleep quality Baseline to 3 months Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire
Trial Locations
- Locations (1)
Virginia Commonwealth University School of Medicine
🇺🇸Richmond, Virginia, United States