Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)

NCT ID: NCT00558194

Last Updated: 2018-03-14

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-01-31

Brief Summary

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Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Standard behavioral weight loss treatment with cognitive and affective skills training

Group Type EXPERIMENTAL

Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training

Intervention Type BEHAVIORAL

12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

2

Standard behavioral weight loss treatment

Group Type ACTIVE_COMPARATOR

Standard Behavioral Weight Loss Treatment

Intervention Type BEHAVIORAL

12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

Interventions

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Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training

12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

Intervention Type BEHAVIORAL

Standard Behavioral Weight Loss Treatment

12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 21 and 70 years
* Body mass index between 27 and 40
* Score 5 or above on the internal disinhibition scale of the Eating Inventory

Exclusion Criteria

* Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
* Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather M. Niemeier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity

Locations

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The Weight Control and Diabetes Research Center, The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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K23DK073536

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23 DK73536-2

Identifier Type: -

Identifier Source: org_study_id

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