Clinical trial NCT03824769: Physical Activity Choices Everyday
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss Maintenance
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University at Buffalo
name: Kent State University
name: University of Southern California
First posted: 2019-01-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry
timeFrame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
measure: Delay Discounting (Adjusting Amount Task)
timeFrame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
measure: Delay Discounting (Monetary Choice Questionnaire)
timeFrame: Phase II baseline to 2 months and 4 months (end of treatment)
Secondary outcomes:
measure: Weight
timeFrame: 4 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: UConn Weight Management Research Laboratory
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Amy Gorin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.