Healthy Eating and Active Living Taught at Home
Condition: Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate two different Parents as Teachers
      curriculums taught by parent educators, during home visits. The control curriculum includes
      only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons
      plus additional information about how families can live healthy and active lives while
      reaching a healthy weight. The investigators hypothesize the intervention lessons will change
      the way people eat and/or their activity level.
    

Detailed description: 
      The primary aim is to test Healthy Eating & Active Living Taught at Home (HEALTH), which
      adapts and integrates the Diabetes Prevention Program lifestyle intervention within Parents
      As Teachers (PAT), a national home visiting program on which many high needs populations rely
      for parent-child information and services. Specific aims 1 and 2 will evaluate the impact of
      HEALTH on lifestyle behaviors and weight of obese mothers and their overweight/obese
      preschool child across multiple PAT regions. Specific aims 3 and 4 will address elements of
      external validity through evaluation of factors that impact the uptake of HEALTH within the
      PAT organization.

      Specific aim 1. Using a group randomized, nested cohort design, evaluate the impact of HEALTH
      on obese women (BMI 30-45 kg/m2; age 18-45 y old) randomized to either control regions
      receiving the standard PAT program, or intervention regions receiving HEALTH.

      Hypothesis 1.1 The primary hypothesis is at the conclusion of the study, when compared to the
      control group, participants in HEALTH will achieve a 7% weight loss at 12 months and maintain
      a 5% weight loss at 24 months, which will be at least two-fold greater than that achieved in
      the control group.

      The secondary hypotheses are that at the conclusion of the study, when compared to the
      control group, participants in HEALTH will significantly:

      Hypothesis 1.2 Improve clinical outcomes of waist circumference and systolic and diastolic
      blood pressure; Hypothesis 1.3 Improve knowledge of evidence-based lifestyle behaviors and
      quality of life; Hypothesis 1.4 Decrease caloric intake Hypothesis 1.5 Increase moderate
      intensity walking.

      Specific aim 2. The secondary aim is to determine whether improvements in 'mother to child'
      behaviors of HEALTH participants will explain all or part of changes in the weight trajectory
      of the participant's overweight (>85th percentile) or obese (>95th percentile) preschool
      child. The hypotheses are that at the conclusion of the study, when compared to the control
      group:

      Hypothesis 2.1 There will be a significantly greater proportion of participants in the HEALTH
      group who improve child feeding practices with their preschool child; Hypothesis 2.2 There
      will be a significantly greater proportion of preschool children in the HEALTH group who
      maintain or reduce their weight as measured by BMI Z-score.

      Specific aim 3. The aim is to assess and provide information on the external validity of
      HEALTH to enhance research translation (e.g. reach and representativeness, program
      implementation or adaptation, decision making outcomes, and maintenance or
      institutionalization).

      Question 3.1 Are HEALTH adopters representative of control PAT participants and parent
      educators? Question 3.2 Are HEALTH parent educators effectively trained to deliver the
      intervention? Question 3.3 Is HEALTH implemented as designed or adapted for content,
      consistency, or intensity? Question 3.4 Is HEALTH maintained as an institutionalized
      component of PAT practice? Specific aim 4. The aim is to determine the cost-utility of HEALTH
      in decreasing obesity and risk for diabetes from two perspectives: the service provider and
      state health agencies.

      Question 4.1 Is the implementation and maintenance of HEALTH effective from a cost-utility
      perspective for the participants enrolled in the program and the agencies considering
      implementing these programs? Question 4.2 Is HEALTH effective in improving health quality,
      from the perspective of state agencies considering funding decisions for this and similar
      programs?
    

Intervention name(s): PAT Curriculum + Health Information
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention group will receive the standard PAT curriculum plus information about healthy eating and an active lifestyle. This curriculum will be taught during up to 36 home visits in two years. Months 1-3 the visits are weekly; months 4-6 visits are biweekly; months 7-24 visits are monthly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Obesity; Home visiting