ObesityPACENCT03843099
Physical Activity Choices Everyday- A Pilot Study
A study testing Behavioral Weight Loss + Future Thinking and Behavioral Weight Loss + Healthy Thinking in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss + Future Thinking and Behavioral Weight Loss + Healthy Thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 17 May 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70
- Body Mass Index between 30-50
- English Speaking
- Have a smartphone that can be used for study activities
Who cannot join
- Report being unable to walk 2 blocks without stopping
- Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
- Are pregnant or plan to become pregnant within 2 months
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
- History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
- Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
- Have no Internet access or unwilling to use personal smartphone for study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Weight Management Research Laboratory
Hartford, Connecticut, 06103
About this study
Official title: Decisions About Exercise During Weight Loss: Pilot Study
This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss + Future Thinking, Behavioral Weight Loss + Healthy Thinking
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss + Future ThinkingBehavioural
Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
Behavioral Weight Loss + Healthy ThinkingBehavioural
Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss + Healthy Thinking | Active comparator | Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Receives: Behavioral: Behavioral Weight Loss + Healthy Thinking |
| Behavioral Weight Loss + Future Thinking | Experimental | Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Receives: Behavioral: Behavioral Weight Loss + Future Thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during 7 day time periods.
Measured: baseline and week 7
Delay Discounting
Change in delay discounting measured using a choice task.
Measured: baseline and week 7
Secondary outcomes (1)
Weight
Weight change from baseline to post treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Mar 2019
- Primary completion17 May 2019
- Study completion17 May 2019
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University at Buffalo, Kent State University, University of Southern California
- Responsible party
- Principal investigator, Amy Gorin, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843099
- Sponsor's protocol ID
- H19-008
- Acronym
- PACE
- Status last verified
- Aug 2019
- First submitted
- 13 Feb 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisions About Exercise During Weight Loss: Pilot Study
- ClinicalTrials.gov ID
- NCT03843099
- Acronym / sponsor ID
- PACE / H19-008
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University at Buffalo, Kent State University, University of Southern California
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 15 Feb 2019 (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.
This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss + Healthy Thinking | Active comparator | Behavioral: Behavioral Weight Loss + Healthy ThinkingParticipants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. |
| Behavioral Weight Loss + Future Thinking | Experimental | Behavioral: Behavioral Weight Loss + Future ThinkingParticipants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-70
- Body Mass Index between 30-50
- English Speaking
- Have a smartphone that can be used for study activities
Key exclusion criteria (8 listed)
- Report being unable to walk 2 blocks without stopping
- Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
- Are pregnant or plan to become pregnant within 2 months
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
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 |
|---|---|---|
| Behavioral Weight Loss + Future ThinkingParticipants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. | Behavioural | Behavioral Weight Loss + Future Thinking |
| Behavioral Weight Loss + Healthy ThinkingParticipants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills. | Behavioural | Behavioral Weight Loss + Healthy Thinking |
Primary outcome
Physical Activity
Time frame: baseline and week 7
Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during 7 day time periods.
Delay Discounting
Time frame: baseline and week 7
Change in delay discounting measured using a choice task.
1 secondary outcome
Weight
Time frame: 4 weeks
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 4 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss + Future Thinking and Behavioral Weight Loss + Healthy Thinking in people with Obesity, run by University of Connecticut 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 8 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 4 Sep 2019. 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?
Physical Activity (time frame: baseline and week 7). The study lists 2 primary outcomes in all. 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 4 Sep 2019.