NCT00877994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

April 6, 2009

Last Update Submit

May 17, 2016

Conditions

Keywords

Disordered EatingParentingMothers

Outcome Measures

Primary Outcomes (1)

  • Parenting self-efficacy

    7 months

Study Arms (2)

Immediate

ACTIVE COMPARATOR

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

Behavioral: Nurture Support Group TherapyBehavioral: Group therapy

Delayed

ACTIVE COMPARATOR

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

Behavioral: Nurture Support Group TherapyBehavioral: Group therapy

Interventions

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.

Also known as: Parenting group
DelayedImmediate
Group therapyBEHAVIORAL

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.

Also known as: Parenting groups
DelayedImmediate

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cynthia Bulik, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Nancy Zucker, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Suzanne Mazzeo, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 8, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations