NCT01693913

Brief Summary

That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.

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 Oct 2012

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

September 21, 2012

Last Update Submit

December 27, 2013

Conditions

Weight

Outcome Measures

Primary Outcomes (1)

  • weight

    Direct measurement of weight

    baseline, months 3,6,12, 24

Study Arms (2)

Cognitive-behavioral

EXPERIMENTAL

Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks

Behavioral: cognitive behavioral exercise and nutrition over

Nurtition education

ACTIVE COMPARATOR

This arm will participate in nutrition and exercise education

Behavioral: nutrition and exercise education

Interventions

cognitive behavioral exercise and nutrition overBEHAVIORAL
Cognitive-behavioral
nutrition and exercise educationBEHAVIORAL
Nurtition education

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Ages 21-60
  • Body mass index 30-40 kg/m2

You may not qualify if:

  • Pregnancy
  • Medications for a psychological disorder
  • Contraindications for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YMCA of Metro Atlanta

Atlanta, Georgia, 30303, United States

Location

Related Publications (3)

  • Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.

    PMID: 22529754BACKGROUND

  • Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.

    PMID: 21780982BACKGROUND

  • Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.

    PMID: 21462690BACKGROUND

MeSH Terms

Conditions

Body Weight

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • James J Annesi, PhD

    YMCA of Metro Atlanta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 26, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

US(1)