- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824769
Physical Activity Choices Everyday (PACE)
December 8, 2023 updated by: Amy Gorin, University of Connecticut
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06103
- UConn Weight Management Research Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18-70
- Body Mass Index between 30-50
- English Speaking
- Have a smartphone that can be used for study activities
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Behavioral Weight Loss Maintenance + Healthy Thinking
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.
|
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.
|
Experimental: Behavioral Weight Loss Maintenance Treatment + Future Thinking
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
|
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.
|
Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
|
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.
|
Phase II baseline to 2 months and 4 months (end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 4 months
|
Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy Gorin, PhD, University of Connecticut
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2019
Primary Completion (Actual)
May 3, 2021
Study Completion (Actual)
May 3, 2021
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H18-153
- R21NR018359 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Weight Loss Maintenance + Healthy Thinking
-
University of ConnecticutNational Institute of Nursing Research (NINR); University of Southern California and other collaboratorsCompleted
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
The Miriam HospitalCompleted
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Completed
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompleted
-
Boston Children's HospitalUniversity of Alabama at Birmingham; Indiana University; Baylor University; Framingham...Terminated
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
University of HelsinkiFinnish Medical FoundationCompleted
-
University of HawaiiQueen's Medical Center; I Ola Lahui, Inc.; Ke Ola Mamo; Queen Lili'uokalani Children... and other collaboratorsCompletedObesity | Overweight | Weight Loss | Weight Loss MaintenanceUnited States
-
Johns Hopkins Bloomberg School of Public HealthMushroom CouncilCompleted