Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT01567033
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2012-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Eating and Active Living Taught at Home
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Translating a Weight Loss Intervention Through a National Home Visiting Program
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEALTH
Brief 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?
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?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: