Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01567033 |
| Other study ID # |
201103147 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2012 |
| Est. completion date |
May 31, 2016 |
Study information
| Verified date |
February 2022 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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?
