Nurture: A Program for Mothers With Histories of Disordered Eating

Eating Disorders Clinical Trial

Official title:

Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877994
• Other study ID #: 08-0236
• Secondary ID: R34MH080750
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: May 17, 2016
• Start date: April 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting self-efficacy		7 months	No