A Novel Approach to Reducing Adiposity Among Young Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-07-01

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.

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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.

Conditions

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Weight Loss Men Lifestyle Risk Reduction Cardiovascular Diseases Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Delayed Treatment Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Lifestyle group

Participants will receive the treatment immediately

Group Type EXPERIMENTAL

Self-guided lifestyle intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No