ObesityNCT02777762
Strategies to Promote Physical Activity
A study testing Fun First and Close at Hand in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Getting regular physical activity has many health benefits. Current physical activity programs often encourage people to track their physical activity as a way to motivate them to continue being physically active over time. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Fun First and Close at Hand
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to Jul 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 ≤ BMI ≤ 39 kg/m2
- Systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg
- Not currently taking medications for blood pressure
Who cannot join
- Not free of diagnosed heart disease, diabetes, and cancer
- Medical contraindications to regular, unsupervised physical activity
- Not stable on all medications over the past 3 months
- Not free of binge eating disorder or bulimic compensatory symptoms
- No regular access to a mobile phone and Internet
- Not able to speak and understand English
Show all 9Show fewer
- Currently pregnant or planning to be within the next year
- Planning to move in the next year
- Not willing to be randomized
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Getting regular physical activity has many health benefits. Current physical activity programs often encourage people to track their physical activity as a way to motivate them to continue being physically active over time. However, not everyone enjoys physical activity, so tracking physical activity may not be very motivating. This research study will evaluate whether a new program-specifically designed to enhance people's enjoyment of physical activity-improves people's attitudes toward physical activity compared to a program that encourages people to track their physical activity with a mobile app.
- Conditions
- Obesity
- Being tested
- Fun First, Close at Hand
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fun FirstBehavioural
8 weekly interactive small-group sessions with a health coach
Close at HandBehavioural
8 weekly check-ins with a state of the art, engaging mobile app
| Study group | Role | What they receive |
|---|---|---|
| Fun First | Experimental | Strategies to promote enjoyment of physical activity Receives: Behavioral: Fun First |
| Close at Hand | Active comparator | Strategies to promote tracking of physical activity Receives: Behavioral: Close at Hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported enjoyment of physical activity assessed with the Behavioral Regulation in Exercise Questionnaire Version 2 (BREQ-2) Intrinsic Regulation subscale
Survey questions
Measured: Change from baseline to 2 months
Secondary outcomes (1)
Change in self-reported physical activity assessed with the Stanford Leisure-Time Categorical Item (L-Cat)
Survey question
Measured: Change from baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michaela Kiernan, Stanford University
- Investigators
- Michaela Kiernan, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777762
- Sponsor's protocol ID
- 37737
- Other IDs
- R01HL128666
- Status last verified
- May 2024
- First submitted
- 6 May 2016
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Promote Physical Activity
- ClinicalTrials.gov ID
- NCT02777762
- Acronym / sponsor ID
- 37737
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 19 May 2016 (estimated)
- 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.
Getting regular physical activity has many health benefits. Current physical activity programs often encourage people to track their physical activity as a way to motivate them to continue being physically active over time. However, not everyone enjoys physical activity, so tracking physical activity may not be very motivating. This research study will evaluate whether a new program-specifically designed to enhance people's enjoyment of physical activity-improves people's attitudes toward physical activity compared to a program that encourages people to track their physical activity with a mobile app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fun First | Experimental | Behavioral: Fun FirstStrategies to promote enjoyment of physical activity |
| Close at Hand | Active comparator | Behavioral: Close at HandStrategies to promote tracking of physical activity |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25 ≤ BMI ≤ 39 kg/m2
- Systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg
- Not currently taking medications for blood pressure
Key exclusion criteria (9 listed)
- Not free of diagnosed heart disease, diabetes, and cancer
- Medical contraindications to regular, unsupervised physical activity
- Not stable on all medications over the past 3 months
- Not free of binge eating disorder or bulimic compensatory symptoms
- No regular access to a mobile phone and Internet
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 |
|---|---|---|
| Fun First8 weekly interactive small-group sessions with a health coach | Behavioural | Fun First |
| Close at Hand8 weekly check-ins with a state of the art, engaging mobile app | Behavioural | Close at Hand |
Primary outcome
Change in self-reported enjoyment of physical activity assessed with the Behavioral Regulation in Exercise Questionnaire Version 2 (BREQ-2) Intrinsic Regulation subscale
Time frame: Change from baseline to 2 months
Survey questions
1 secondary outcome
Change in self-reported physical activity assessed with the Stanford Leisure-Time Categorical Item (L-Cat)
Time frame: Change from baseline to 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
Michaela Kiernan, PhD principal investigator
Stanford 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 Fun First and Close at Hand in people with Obesity, run by Stanford 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Jun 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in self-reported enjoyment of physical activity assessed with the Behavioral Regulation in Exercise Questionnaire Version 2 (BREQ-2) Intrinsic Regulation subscale (time frame: Change from baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.