NCT03824769: PACE

Physical Activity Choices Everyday

Completed NA Results posted Last updated 11 December 2023

What this trial tests

NA trial testing Weight Loss Maintenance + Healthy Thinking in Obesity in 160 participants. Completed in 3 May 2021.

Timeline

11 March 2019

Primary endpoint
3 May 2021

3 May 2021

Quick facts

Lead sponsor	University of Connecticut
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	160
Start date	11 March 2019
Primary completion	3 May 2021
Estimated completion	3 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Weight Loss Maintenance + Healthy Thinking
• Weight Loss Maintenance Treatment + Future Thinking

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Connecticut

Who can join

Adults 18 to 70, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry Primary · 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

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	-21.4286	± 61.52851
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-53.9600	± 149.60712

Phase II baseline to 2-month

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	19.6000	± 100.36900
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-38.6800	± 108.40846

Phase II baseline to 4-month

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	-12.7143	± 96.02403
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-65.7308	± 126.15627

Delay Discounting (Adjusting Amount Task) Primary · 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 c

Baseline to 1-month

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	0.001280	± 0.003962
Behavioral Weight Loss Maintenance Treatment + Future Thinking	0.107264	± 0.547971

Baseline to 2-month

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	0.000165	± 0.003824
Behavioral Weight Loss Maintenance Treatment + Future Thinking	0.108922	± 0.558786

Baseline to 4-month

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	-0.000071	± 0.003989
Behavioral Weight Loss Maintenance Treatment + Future Thinking	0.101414	± 0.538400

Delay Discounting (Monetary Choice Questionnaire) Primary · 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

Baseline to 2-months

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	0.002863	± 0.029509
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-0.007161	± 0.017930

Baseline to 4-months

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	-0.001625	± 0.022689
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-0.004049	± 0.015750

Weight Secondary · 4 months

Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program

Group	Value	95% CI
Behavioral Weight Loss Maintenance + Healthy Thinking	-11.87	± 7.66
Behavioral Weight Loss Maintenance Treatment + Future Thinking	-9.28	± 6.63

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking

Serious: 0/24 (0%)

Deaths: 0/24

Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking

Serious: 0/28 (0%)

Deaths: 0/28

Phase I Only (Weight Loss Phase): 16 Weeks

Serious: 2/108 (2%)

Deaths: 0/108

Serious adverse events (2 terms)

Reaction	System	Phase II (RCT): Behavioral…	Phase II (RCT) Behavioral …	Phase I Only (Weight Loss …
Other	General disorders	—	—	—
Motor vehicle accident	Injury, poisoning and procedural complications	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Phase II (RCT): Behavioral…	Phase II (RCT) Behavioral …	Phase I Only (Weight Loss …
Other	General disorders	—	—	—
Muscle or bone injury (e.g., broken bone, torn ligament, sprain)	Injury, poisoning and procedural complications	—	—	—
Gall bladder attack or surgery	Gastrointestinal disorders	—	—	—
New diagnosis, started treatment, or hospitalized for depression	Psychiatric disorders	—	—	—
Stroke, ministroke (TIA), or other neurological problems	Nervous system disorders	—	—	—

Most-reported serious reactions: Other, Motor vehicle accident.

Data from ClinicalTrials.gov NCT03824769 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial.
   Leahey TM, Gorin AA, Wyckoff E, Denmat Z, et al · · 2020 · cited 11× · PMID 32833481 · DOI 10.1037/hea0000860