NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)
This study has been completed.
Sponsor:
Virginia Commonwealth University
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00628030
First received: February 22, 2008
Last updated: January 9, 2015
Last verified: January 2015
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Results First Received: January 6, 2014
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Pediatric Obesity |
| Interventions: |
Behavioral: NOURISH Other: Wellness Group |
Participant Flow
Hide 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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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. |
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| 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 | |
|---|---|---|---|
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Number of Participants
[units: participants] |
92 | 92 | 184 |
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Age
[units: years] Mean (Standard Deviation) |
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| 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) |
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Gender
[units: participants] |
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| Female | 74 | 73 | 147 |
| Male | 18 | 19 | 37 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Child BMI [ Time Frame: Basline, Posttest ] |
| 2. Secondary: | Child Feeding [ Time Frame: Basline, Posttest ] |
| 3. Secondary: | Child Quality of Life [ Time Frame: Basline, Posttest ] |
| 4. Secondary: | Parental BMI [ Time Frame: Baseline, Posttest ] |
| 5. Secondary: | Parental Dietary Intake of Fat [ Time Frame: Baseline, Posttest ] |
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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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
| 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
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | February 22, 2008 |
| Results First Received: | January 6, 2014 |
| Last Updated: | January 9, 2015 |
| Health Authority: | United States: Institutional Review Board |