NCT00558194

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

November 13, 2007

Last Update Submit

March 12, 2018

Conditions

OverweightObesity

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    12 Months

Secondary Outcomes (3)

  • Internal disinhibition as measured by the Eating Inventory

    12 Months

  • Physical activity as measured by the Paffenbarger

    12 months

  • Dietary intake as measured by the Block Food Frequency Questionnaire

    12 months

Study Arms (2)

1

EXPERIMENTAL

Standard behavioral weight loss treatment with cognitive and affective skills training

Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training

2

ACTIVE COMPARATOR

Standard behavioral weight loss treatment

Behavioral: Standard Behavioral Weight Loss Treatment

Interventions

Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills TrainingBEHAVIORAL

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

1
Standard Behavioral Weight Loss TreatmentBEHAVIORAL

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

2

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Weight Control and Diabetes Research Center, The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heather M. Niemeier, Ph.D.

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

US(1)