Weight LossNCT04267263
A Novel Approach to Reducing Adiposity Among Young Men
A study testing Self-guided lifestyle intervention in people with Weight Loss and Men, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Weight Loss, Men, Lifestyle Risk Reduction
- What is being tested?
- Self-guided lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- self-identify as a man
- 18-35 years old
- BMI 25-45kg/m2
- Live in North America
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Weight Loss, Men, Lifestyle Risk Reduction, Cardiovascular Diseases, Obesity
- Being tested
- Self-guided lifestyle intervention
- Medical subject headings
- Weight Loss, Multiple Endocrine Neoplasia Type 1, Risk Reduction Behavior, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Treatment Control group | No intervention | Participants will receive the treatment after completion of the 3-month follow-up assessment |
| Lifestyle group | Experimental | Participants will receive the treatment immediately Receives: Behavioral: Self-guided lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight lost
Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100
Measured: 3 months
Secondary outcomes (4)
Change in perceived risk for heart disease
Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
Measured: Baseline to 3 months
Change in minutes of moderate to vigorous physical activity
Physical activity assessed via 21-item Global Physical Activity Questionnaire
Measured: Baseline to 3 months
Change in diet quality
Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
Measured: Baseline to 3 months
Change in sleep quality
Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start20 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica G LaRose, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267263
- Sponsor's protocol ID
- HM20015458
- Status last verified
- Jul 2021
- First submitted
- 10 Feb 2020
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reading JM, Crane MM, Guan J, Jackman R, Thomson MD, LaRose JG. Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings. JMIR Form Res. 2024 Apr 5;8:e53841. doi: 10.2196/53841.
PubMed 38578686Reading JM, Crane MM, Carlyle K, Perera RA, LaRose JG. A Self-Guided Lifestyle Intervention for Young Men: Findings from the ACTIVATE Randomized Pilot Trial. J Mens Health. 2022;18(9):191. doi: 10.31083/j.jomh1809191. Epub 2022 Sep 14.
PubMed 36846742
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Reducing Adiposity Among Young Men
- ClinicalTrials.gov ID
- NCT04267263
- Acronym / sponsor ID
- HM20015458
- Conditions
- Weight Loss, Men, Lifestyle Risk Reduction, Cardiovascular Diseases, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Treatment Control group | No intervention | –Participants will receive the treatment after completion of the 3-month follow-up assessment |
| Lifestyle group | Experimental | Behavioral: Self-guided lifestyle interventionParticipants will receive the treatment immediately |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- self-identify as a man
- 18-35 years old
- BMI 25-45kg/m2
- Live in North America
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided lifestyle interventionThe 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. | Behavioural | Lifestyle group |
Primary outcome
Percent weight lost
Time frame: 3 months
Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100
4 secondary outcomes
Change in perceived risk for heart disease
Time frame: Baseline to 3 months
Change in minutes of moderate to vigorous physical activity
Time frame: Baseline to 3 months
Change in diet quality
Time frame: Baseline to 3 months
Change in sleep quality
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Derived from this study: PubMed 38578686Reading JM, Crane MM, Guan J, Jackman R, Thomson MD, LaRose JG. Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings. JMIR Form Res. 2024 Apr 5;8:e53841. doi: 10.2196/53841.
- Derived from this study: PubMed 36846742Reading JM, Crane MM, Carlyle K, Perera RA, LaRose JG. A Self-Guided Lifestyle Intervention for Young Men: Findings from the ACTIVATE Randomized Pilot Trial. J Mens Health. 2022;18(9):191. doi: 10.31083/j.jomh1809191. Epub 2022 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica G LaRose, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided lifestyle intervention in people with Weight Loss and Men, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight lost (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.