Nurture: A Program for Mothers With Histories of Disordered Eating - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00877994

Purpose

Nurture is a collaborative pilot study for mothers of children under the age of 3 who have suffered from disordered eating in the past. It is coordinated by the University of North Carolina at Chapel Hill, Duke University and Virginia Commonwealth University and sponsored by the National Institute of Mental Health. Nurture hopes to promote confident parenting and a positive meal times.

Condition	Intervention
Eating Disorders	Behavioral: Nurture Support Group Therapy Behavioral: Group therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders Parenting

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Parenting self-efficacy [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Immediate This group will receive the nurture group therapy immediately after enrolling in the study.	Behavioral: Nurture Support Group Therapy Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. Other Name: Parenting group Behavioral: Group therapy Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles. Other Name: Parenting groups
Active Comparator: Delayed This group will receive the nurture group therapy 16 weeks after enrolling in the study.	Behavioral: Nurture Support Group Therapy Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. Other Name: Parenting group Behavioral: Group therapy Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles. Other Name: Parenting groups

Arms

Assigned Interventions

Active Comparator: Immediate

This group will receive the nurture group therapy immediately after enrolling in the study.

Behavioral: Nurture Support Group Therapy

Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists.

Other Name: Parenting group

Behavioral: Group therapy

Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles.

Other Name: Parenting groups

Active Comparator: Delayed

This group will receive the nurture group therapy 16 weeks after enrolling in the study.

Behavioral: Nurture Support Group Therapy

Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists.

Other Name: Parenting group

Behavioral: Group therapy

Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles.

Other Name: Parenting groups

Detailed Description:

Mothers who have struggled with disordered eating or body image struggles are often concerned how best to provide proper nutrition to their child and/or model healthy eating behavior. We have developed a curriculum that provides information about how to establish healthy eating patterns and social support for mothers with children under three years of age. The curriculum will be delivered in a support group format led by co-therapists affiliated with the UNC Eating Disorder Program.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has met lifetime DSM-IV criteria for anorexia nervosa (AN), bulimia nervosa (BN), or eating disorder not otherwise specified (EDNOS: including subthreshold AN, BN, and purging disorder, but excluding BED)
BMI > 18.5 maintained for at least three months
Has not met threshold criteria for AN or BN in the previous 28 days according to the Eating Disorders Examination, although subthreshold status or active residual symptomatology will not preclude entry
Age 18 or older
Has a child between the ages of 1 month and 2 years, 12 months old

Exclusion Criteria:

Alcohol or drug dependence in the past year
Current significant suicidal ideation reported during the assessment or on the BDI-II at baseline
Developmental disability that would impair the ability of the participant to benefit from the intervention
Psychosis, including schizophrenia, or bipolar I disorder
Any families who have been the subject of social service inquiries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877994

Locations

United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27516

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Cynthia Bulik, PhD	University of North Carolina, Chapel Hill
Principal Investigator:	Nancy Zucker, PhD	Duke University
Principal Investigator:	Suzanne Mazzeo, PhD	Virginia Commonwealth University

More Information

Additional Information:

Nurture

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00877994 History of Changes
Other Study ID Numbers:	08-0236, R34MH080750
Study First Received:	April 6, 2009
Last Updated:	December 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Disordered Eating
Parenting
Mothers

Additional relevant MeSH terms:

Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012