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NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)

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ClinicalTrials.gov Identifier: NCT00628030
Recruitment Status : Completed
First Posted : March 4, 2008
Results First Posted : January 9, 2015
Last Update Posted : January 19, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pediatric Obesity
Interventions: Behavioral: NOURISH
Other: Wellness Group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
NOURISH Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
Wellness Group Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.

Participant Flow for 2 periods

 Period 1:   Baseline to Post-Assessment
    NOURISH   Wellness Group
STARTED   92   92 
COMPLETED   59   63 
NOT COMPLETED   33   29 
Lost to Follow-up                28                29 
Withdrawal by Subject                5                0 

Period 2:   Post to 6 Month Follow-up
    NOURISH   Wellness Group
STARTED   59   63 
COMPLETED   27   33 
NOT COMPLETED   32   30 
Lost to Follow-up                32                30 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Families completed baseline, post, and six-month follow-up assessments. Although baseline and outcome data for parents and children were collected, only parents participated in the intervention: NOURISH (n = 92; 44 parents/caregivers, 48 children). Wellness Group (n = 92; 47 parents/caregivers, 45 children).

Reporting Groups
  Description
NOURISH Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
Wellness Group Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
Total Total of all reporting groups

Baseline Measures
   NOURISH   Wellness Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 92   92   184 
Age 
[Units: Years]
Mean (Standard Deviation) 		     
Adult Age   38.80  (6.71)   40.32  (7.81)   39.90  (7.40) 
Child Age   8.70  (1.47)   8.48  (1.53)   8.60  (1.50) 
Gender 
[Units: Participants]
 		     
Female   74   73   147 
Male   18   19   37 


  Outcome Measures

1.  Primary:   Child BMI   [ Time Frame: Basline, Posttest ]
  Show Outcome Measure 1

2.  Secondary:   Child Feeding   [ Time Frame: Basline, Posttest ]
  Show Outcome Measure 2

3.  Secondary:   Child Quality of Life   [ Time Frame: Basline, Posttest ]
  Show Outcome Measure 3

4.  Secondary:   Parental BMI   [ Time Frame: Baseline, Posttest ]
  Show Outcome Measure 4

5.  Secondary:   Parental Dietary Intake of Fat   [ Time Frame: Baseline, Posttest ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Suzanne E Mazzeo, Professor of Psychology
Organization: Virginia Commonwealth University
phone: 804-827-9211
e-mail: semazzeo@vcu.edu



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00628030     History of Changes
Other Study ID Numbers: PT101376
1R03HD056050-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2008
First Posted: March 4, 2008
Results First Submitted: January 6, 2014
Results First Posted: January 9, 2015
Last Update Posted: January 19, 2015