- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877994
Nurture: A Program for Mothers With Histories of Disordered Eating
May 17, 2016 updated by: University of North Carolina, Chapel Hill
Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27516
- University of North Carolina Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Immediate
This group will receive the nurture group therapy immediately after enrolling in the study.
|
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 Names:
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 Names:
|
Active Comparator: Delayed
This group will receive the nurture group therapy 16 weeks after enrolling in the study.
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parenting self-efficacy
Time Frame: 7 months
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nancy Zucker, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
April 8, 2009
Study Record Updates
Last Update Posted (Estimate)
May 19, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0236
- R34MH080750 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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