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Nurture: A Program for Mothers With Histories of Disordered Eating

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurture Support Group Therapy
Group therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Disordered Eating, Parenting, Mothers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate

Delayed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Parenting self-efficacy

Secondary Outcome Measures

Full Information

First Posted
April 6, 2009
Last Updated
May 17, 2016
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00877994
Brief Title
Nurture: A Program for Mothers With Histories of Disordered Eating
Official Title
Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Disordered Eating, Parenting, Mothers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Active Comparator
Arm Description
This group will receive the nurture group therapy immediately after enrolling in the study.
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
This group will receive the nurture group therapy 16 weeks after enrolling in the study.
Intervention Type
Behavioral
Intervention Name(s)
Nurture Support Group Therapy
Other Intervention Name(s)
Parenting group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group therapy
Other Intervention Name(s)
Parenting groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parenting self-efficacy
Time Frame
7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Bulik, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Zucker, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne Mazzeo, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Nurture: A Program for Mothers With Histories of Disordered Eating

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