NCT03843099

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

February 13, 2019

Last Update Submit

August 31, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physical Activity

    Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during 7 day time periods.

    baseline and week 7

  • Delay Discounting

    Change in delay discounting measured using a choice task.

    baseline and week 7

Secondary Outcomes (1)

  • Weight

    4 weeks

Study Arms (2)

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.

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.

Behavioral: Behavioral Weight Loss + Future Thinking

Interventions

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 + Future Thinking

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 Thinking

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-70
  • Body Mass Index between 30-50
  • English Speaking
  • Have a smartphone that can be used for study activities

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Weight Management Research Laboratory

Hartford, Connecticut, 06103, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 15, 2019

Study Start

March 11, 2019

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

September 4, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations