Trial Outcomes & Findings for NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NCT NCT00628030)

NCT ID: NCT00628030

Last Updated: 2015-01-19

Results Overview

Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 184 participants
• Primary outcome timeframe: Basline, Posttest
• Results posted on: 2015-01-19

Participant Flow

Participant milestones

Measure	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.
Baseline to Post-Assessment STARTED	92	92
Baseline to Post-Assessment COMPLETED	59	63
Baseline to Post-Assessment NOT COMPLETED	33	29
Post to 6 Month Follow-up STARTED	59	63
Post to 6 Month Follow-up COMPLETED	27	33
Post to 6 Month Follow-up NOT COMPLETED	32	30

Reasons for withdrawal

Measure	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.
Baseline to Post-Assessment Lost to Follow-up	28	29
Baseline to Post-Assessment Withdrawal by Subject	5	0
Post to 6 Month Follow-up Lost to Follow-up	32	30

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NOURISH n=92 Participants 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 n=92 Participants 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 n=184 Participants Total of all reporting groups
Age, Continuous Adult Age	38.80 years STANDARD_DEVIATION 6.71 • n=5 Participants	40.32 years STANDARD_DEVIATION 7.81 • n=7 Participants	39.90 years STANDARD_DEVIATION 7.40 • n=5 Participants
Age, Continuous Child Age	8.70 years STANDARD_DEVIATION 1.47 • n=5 Participants	8.48 years STANDARD_DEVIATION 1.53 • n=7 Participants	8.60 years STANDARD_DEVIATION 1.50 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	73 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Basline, Posttest

Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.

Outcome measures

Measure	NOURISH n=48 Participants 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 n=45 Participants 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.
Child BMI Baseline	98.47 percentile Standard Deviation 2.24	97.86 percentile Standard Deviation 2.67
Child BMI Post-test (12 wks -waves 1-2; 6 weeks-waves 3+)	98.19 percentile Standard Deviation 2.73	97.86 percentile Standard Deviation 2.61

SECONDARY outcome

Timeframe: Basline, Posttest

The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale "concern about child's weight" is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test).

Outcome measures

Measure	NOURISH n=43 Participants 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 n=41 Participants 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.
Child Feeding	-0.16 units on a scale Standard Deviation 0.44	-0.03 units on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: Basline, Posttest

Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest

We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.

We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.

The current report did not provide subscores.

Outcome measures

Measure	NOURISH n=48 Participants 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 n=45 Participants 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.
Child Quality of Life	3.47 units on a scale Standard Deviation 12.15	1.46 units on a scale Standard Deviation 10.88

SECONDARY outcome

Timeframe: Baseline, Posttest

Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.

Outcome measures

Measure	NOURISH n=44 Participants 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 n=47 Participants 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.
Parental BMI	.42 kg/m^2 Standard Deviation 1.84	-.65 kg/m^2 Standard Deviation 2.96

SECONDARY outcome

Timeframe: Baseline, Posttest

Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.

Outcome measures

Measure	NOURISH n=44 Participants 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 n=47 Participants 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.
Parental Dietary Intake of Fat	-6.15 grams Standard Deviation 13.66	-0.42 grams Standard Deviation 15.35

Adverse Events

NOURISH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wellness Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne E Mazzeo, Professor of Psychology

Virginia Commonwealth University

Phone: 804-827-9211

Email: semazzeo@vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place