Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

NCT ID: NCT02487121

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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variable interval schedule

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

Group Type EXPERIMENTAL

variable interval schedule

Intervention Type BEHAVIORAL

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

self-directed treatment

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

Group Type ACTIVE_COMPARATOR

self-directed treatment

Intervention Type BEHAVIORAL

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

Interventions

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variable interval schedule

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

Intervention Type BEHAVIORAL

self-directed treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Gareth R. Dutton PhD

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 35725143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28806992 (View on PubMed)

Other Identifiers

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K23DK081607

Identifier Type: NIH

Identifier Source: org_study_id

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