Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health - FAMILIA

Contribution To Literature:

The FAMILIA trial failed to show that lifestyle intervention was effective at improving a composite health score among parents/caregivers of preschool children.


The goal of the trial was to evaluate lifestyle intervention compared with control on a composite health score of the parents/caregivers of preschool children.

Study Design

  • Cluster randomized trial
  • Parallel

Preschool children enrolled in the Head Start program in Harlem, New York were randomized (at the school level) to intervention (n = 513) versus control (n = 207). The intervention group consisted of an Intensive Individual Intervention program (individual counseling sessions) or a Peer-to-Peer Program Intervention (monthly group meetings).

  • Total number of enrollees: 635
  • Duration of follow-up: 2 years
  • Mean parent/caregiver age: 38 years
  • Percentage female: 83%

Inclusion criteria:

  • Preschool children enrolled in the Head Start program

Principal Findings:

The primary outcome was the FBS, which is a composite health score consisting of blood pressure, exercise, weight, alimentation, and tobacco. An FBS of 15 represents ideal health. The mean FBS was 9.3 points.

The change from baseline to 12 months in FBS was 0.2 in the intervention group compared with 0.2 in the control care group (p = not significant). The results were the same at 24 months.

Secondary outcomes: Among those with good adherence, intervention vs. control was associated with an increase in FBS of 0.3 (p = 0.025). Among those with poor adherence, intervention vs. control was associated with no change in FBS (p = 1.0).


Among patients/caregivers of preschool children, an intervention program was not effective at improving a composite health score at 12 months. There was suggestion for slight benefit among those with good adherence to the program; however, the clinical benefit from a 0.3-point increase in the composite health score appears marginal.


Fernandez-Jimenez R, Jaslow R, Bansilal S, et al. Different Lifestyle Interventions in Adults From Underserved Communities: The FAMILIA Trial. J Am Coll Cardiol 2019;Nov 11:[Epub ahead of print].

Presented by Dr. Valentin Fuster at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 17, 2019.

Keywords: AHA Annual Scientific Sessions, AHA19, Blood Pressure, Body Weight, Caregivers, Child, Preschool, Counseling, Early Intervention, Educational, Exercise, Life Style, Metabolic Syndrome, Primary Prevention, Tobacco Use

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