Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers
Brief Summary: The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children.

Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender.

Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group.

Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention.

Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group.

Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI.

Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).


Options:
A: Arm Label: parent-targeted intervention; Type: EXPERIMENTAL; Interventions: Behavioral: multi-component/setting parent-targeted intervention | Arm Label: Primary Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: multi-component/setting parent-targeted intervention; Assigned to Arm(s): parent-targeted intervention
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 3
C: Arm Label: parent intervention plus gym lessons; Type: EXPERIMENTAL; Interventions: Behavioral: parent-focused intervention, Behavioral: twice weekly gym lessons | Arm Label: gym lessons only; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: twice weekly gym lessons | Intervention Type: BEHAVIORAL; Name: parent-focused intervention; Assigned to Arm(s): parent intervention plus gym lessons | Intervention Type: BEHAVIORAL; Name: twice weekly gym lessons; Assigned to Arm(s): gym lessons only, parent intervention plus gym lessons
D: Arm Label: Optimisation + HENRY; Type: EXPERIMENTAL; Interventions: Behavioral: Optimisation + HENRY | Arm Label: HENRY as standard; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HENRY as standard | Intervention Type: BEHAVIORAL; Name: Optimisation + HENRY; Assigned to Arm(s): Optimisation + HENRY | Intervention Type: BEHAVIORAL; Name: HENRY as standard; Assigned to Arm(s): HENRY as standard

Answer: A