NCT00533052

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 is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. 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

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

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

September 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

September 20, 2007

Last Update Submit

March 12, 2018

Conditions

OverweightObesity

Keywords

Behavioral weight loss

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    6 months

Secondary Outcomes (3)

  • Internal disinhibition as measured by the Eating Inventory

    6 months

  • Treatment acceptability based on qualitative feedback

    6 months

  • Attendance data

    6 months

Study Arms (1)

Affective and Cognitive Skills Training

EXPERIMENTAL

Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training

Behavioral: Affective and Cognitive Skills Training

Interventions

Affective and Cognitive Skills TrainingBEHAVIORAL

24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Affective and Cognitive Skills Training

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 Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Niemeier HM, Leahey T, Palm Reed K, Brown RA, Wing RR. An acceptance-based behavioral intervention for weight loss: a pilot study. Behav Ther. 2012 Jun;43(2):427-35. doi: 10.1016/j.beth.2011.10.005. Epub 2011 Dec 1.

    PMID: 22440077RESULT

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heather M. Niemeier, Ph.D.

    The Miriam Hospital/The Warren Alpert Medical School of Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 21, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

US(1)