A Novel Approach to Reducing Adiposity Among Young Men

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Weight Loss; Lifestyle Risk Reduction; Men; Obesity; Cardiovascular Diseases

Treatments: Behavioral: Self-guided lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04267263

HM20015458

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Delayed Treatment Control group

No Intervention group

Description:

Participants will receive the treatment after completion of the 3-month follow-up assessment

Lifestyle group

Experimental group

Description:

Participants will receive the treatment immediately

Treatment:

Behavioral: Self-guided lifestyle intervention