ObesityPACENCT03824769
Physical Activity Choices Everyday
A study testing Weight Loss Maintenance + Healthy Thinking and Weight Loss Maintenance Treatment + Future 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 maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Weight Loss Maintenance + Healthy Thinking and Weight Loss Maintenance Treatment + Future Thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 3 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year
- 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: Is Long-term Maintenance Worth the Wait? Using Real Time Data Capture to Examine Delayed Discounting as a Putative Target of Physical Activity Adherence in Weight Loss Maintenance Interventions
This study aims to test two strategies for weight loss maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and weekly personalized feedback on diet, activity, and weight loss goals. Individuals who lose at least 5% of their initial body weight during this program, will be invited to participate in Phase II. During Phase II, two 4-month treatments for weight loss maintenance will be tested. At the beginning of Phase II, participants will be randomly assigned to one of the two maintenance programs: (1) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance program that involves in-person group meetings 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
- Weight Loss Maintenance + Healthy Thinking, Weight Loss Maintenance Treatment + Future Thinking
- Keywords
- Weight Loss Maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Maintenance + Healthy ThinkingBehavioural
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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.
Weight Loss Maintenance Treatment + Future ThinkingBehavioural
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss Maintenance + Healthy Thinking | Active comparator | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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: Weight Loss Maintenance + Healthy Thinking |
| Behavioral Weight Loss Maintenance Treatment + Future Thinking | Experimental | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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: Weight Loss Maintenance Treatment + Future Thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry
Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.
Measured: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Delay Discounting (Adjusting Amount Task)
Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant's choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.
Measured: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Delay Discounting (Monetary Choice Questionnaire)
Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.
Measured: Phase II baseline to 2 months and 4 months (end of treatment)
Secondary outcomes (1)
Weight
Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start11 Mar 2019
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 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
- Investigators
- Amy Gorin, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824769
- Sponsor's protocol ID
- H18-153
- Other IDs
- R21NR018359
- Acronym
- PACE
- Status last verified
- Dec 2023
- First submitted
- 29 Jan 2019
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leahey TM, Gorin AA, Wyckoff E, Denmat Z, O'Connor K, Field C, Dunton GF, Gunstad J, Huedo-Medina TB, Gilder C. Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial. Health Psychol. 2020 Sep;39(9):796-805. doi: 10.1037/hea0000860.
PubMed 32833481
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Long-term Maintenance Worth the Wait? Using Real Time Data Capture to Examine Delayed Discounting as a Putative Target of Physical Activity Adherence in Weight Loss Maintenance Interventions
- ClinicalTrials.gov ID
- NCT03824769
- Acronym / sponsor ID
- PACE / H18-153
- Conditions
- Obesity
- Keywords
- Weight Loss Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 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
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 11 Dec 2023
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 maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and weekly personalized feedback on diet, activity, and weight loss goals. Individuals who lose at least 5% of their initial body weight during this program, will be invited to participate in Phase II. During Phase II, two 4-month treatments for weight loss maintenance will be tested. At the beginning of Phase II, participants will be randomly assigned to one of the two maintenance programs: (1) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance program that involves in-person group meetings 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss Maintenance + Healthy Thinking | Active comparator | Behavioral: Weight Loss Maintenance + Healthy ThinkingContingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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 Maintenance Treatment + Future Thinking | Experimental | Behavioral: Weight Loss Maintenance Treatment + Future ThinkingContingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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 1 year
- 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 |
|---|---|---|
| Weight Loss Maintenance + Healthy ThinkingContingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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. | Behavioural | Behavioral Weight Loss Maintenance + Healthy Thinking |
| Weight Loss Maintenance Treatment + Future ThinkingContingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management 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. | Behavioural | Behavioral Weight Loss Maintenance Treatment + Future Thinking |
Primary outcome
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry
Time frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.
Delay Discounting (Adjusting Amount Task)
Time frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant's choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.
Delay Discounting (Monetary Choice Questionnaire)
Time frame: Phase II baseline to 2 months and 4 months (end of treatment)
Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.
1 secondary outcome
Weight
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32833481Leahey TM, Gorin AA, Wyckoff E, Denmat Z, O'Connor K, Field C, Dunton GF, Gunstad J, Huedo-Medina TB, Gilder C. Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial. Health Psychol. 2020 Sep;39(9):796-805. doi: 10.1037/hea0000860.
- 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.
Amy Gorin, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Maintenance + Healthy Thinking and Weight Loss Maintenance Treatment + Future 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 11 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (time frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)). The study lists 3 primary outcomes in all. 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 NCT03824769, which also lists 1 linked publication.
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 11 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.