Clinical trial NCT04267263: A Novel Approach to Reducing Adiposity Among Young Men
Official title: A Novel Approach to Reducing Adiposity Among Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Men
Lifestyle Risk Reduction
Cardiovascular Diseases
Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. self-identify as a man
2. 18-35 years old
3. BMI 25-45kg/m2
4. Live in North America

Exclusion Criteria:

1. an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
2. a diagnosis of Type 1 or Type 2 diabetes
3. 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
4. currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
5. change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
6. have lost \> 5% body weight within the last 3 months
7. report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
8. report hospitalization for a psychiatric condition within the last year
9. report high alcohol intake (AUDIT score \> 16).
10. are not able to speak and read English
11. do not possess a mobile device or are unwilling to use it to receive study text messages
12. 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).

Primary outcomes:
measure: Percent weight lost
timeFrame: 3 months
Secondary outcomes:
measure: Change in perceived risk for heart disease
timeFrame: Baseline to 3 months
measure: Change in minutes of moderate to vigorous physical activity
timeFrame: Baseline to 3 months
measure: Change in diet quality
timeFrame: Baseline to 3 months
measure: Change in sleep quality
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jessica G LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References: