NCT02487121

Brief Summary

This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable obesity

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

4.9 years

First QC Date

June 26, 2015

Last Update Submit

June 29, 2015

Conditions

Obesity

Keywords

weight loss

Outcome Measures

Primary Outcomes (1)

  • body weight (kg)

    change in body weight (kg) between randomization and month-12 follow-up

    12 months

Study Arms (2)

variable interval schedule

EXPERIMENTAL

12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period

Behavioral: variable interval schedule

self-directed treatment

ACTIVE COMPARATOR

provision of treatment materials with instruction to work through materials at participant's own pace

Behavioral: self-directed treatment

Interventions

variable interval scheduleBEHAVIORAL

12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period

variable interval schedule
self-directed treatmentBEHAVIORAL

provision of treatment materials with instruction to work through materials at participant's own pace

self-directed treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 21 years-old
  • body mass index (BMI) = 28.0 - 45.0 kg/m2
  • willing to provide informed consent and accept randomization

You may not qualify if:

  • BMI \>45 kg/m2
  • Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
  • Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Schneider-Worthington CR, Kinsey AW, Tan F, Zhang S, Borgatti AC, Davis AL, Dutton GR. Pretreatment and During-Treatment Weight Trajectories in Black and White Women. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S67-S74. doi: 10.1016/j.amepre.2022.01.031.

    PMID: 35725143DERIVED

  • Dutton GR, Gowey MA, Tan F, Zhou D, Ard J, Perri MG, Lewis CE. Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Int J Behav Nutr Phys Act. 2017 Aug 15;14(1):107. doi: 10.1186/s12966-017-0564-1.

    PMID: 28806992DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 1, 2015

Study Start

April 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 1, 2015

Record last verified: 2015-06