A Novel Approach to Reducing Adiposity Among Young Men

Obesity Clinical Trial

Official title:

A Novel Approach to Reducing Adiposity Among Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267263
• Other study ID #: HM20015458
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle Risk Reduction
• Men
• Obesity
• Weight Loss

Intervention

Behavioral:
• Self-guided lifestyle intervention
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Medicine	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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