Trial Outcomes & Findings for Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I) (NCT NCT03758638)
NCT ID: NCT03758638
Last Updated: 2025-11-12
Results Overview
Mother's body weight assessed by data collector
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
620 participants
Primary outcome timeframe
24-months
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Healthy Eating & Active Living Taught at Home
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
Healthy Eating \& Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
|
Usual Care
Participants at usual care PAT sites will receive PAT as usual
Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
|
|---|---|---|
|
Overall Study
STARTED
|
349
|
271
|
|
Overall Study
COMPLETED
|
79
|
62
|
|
Overall Study
NOT COMPLETED
|
270
|
209
|
Reasons for withdrawal
| Measure |
Healthy Eating & Active Living Taught at Home
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
Healthy Eating \& Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
|
Usual Care
Participants at usual care PAT sites will receive PAT as usual
Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
|
|---|---|---|
|
Overall Study
Pregnancy
|
17
|
25
|
|
Overall Study
Lost to Follow-up
|
60
|
54
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Providers not included in the primary outcome.
|
183
|
128
|
Baseline Characteristics
As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
Baseline characteristics by cohort
| Measure |
Healthy Eating & Active Living Taught at Home
n=349 Participants
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
Healthy Eating \& Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
|
Usual Care
n=271 Participants
Participants at usual care PAT sites will receive PAT as usual
Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
|
Total
n=620 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age of participant
|
30.3 Years
STANDARD_DEVIATION 5.6 • n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
31.2 Years
STANDARD_DEVIATION 6.1 • n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
30.7 Years
STANDARD_DEVIATION 5.8 • n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Age, Continuous
Age of provider
|
39.75 Years
STANDARD_DEVIATION 12.05 • n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
40.11 Years
STANDARD_DEVIATION 12.04 • n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
39.93 Years
STANDARD_DEVIATION 12.05 • n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Sex: Female, Male
Sex of participant · Female
|
166 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
143 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
309 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Sex: Female, Male
Sex of participant · Male
|
0 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
0 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
0 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Sex: Female, Male
Sex of provider · Female
|
182 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
128 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
310 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Sex: Female, Male
Sex of provider · Male
|
1 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
0 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
1 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of participant · Hispanic or Latino
|
68 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
62 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
130 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of participant · Not Hispanic or Latino
|
89 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
67 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
156 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of participant · Unknown or Not Reported
|
9 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
14 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
23 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of provider · Hispanic or Latino
|
58 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
36 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
94 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of provider · Not Hispanic or Latino
|
114 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
80 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
194 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Ethnicity (NIH/OMB)
Ethnicity of provider · Unknown or Not Reported
|
11 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
12 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
23 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · American Indian or Alaska Native
|
0 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
1 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
1 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · Asian
|
4 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
1 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
5 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
2 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
3 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · Black or African American
|
25 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
15 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
40 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · White
|
93 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
66 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
159 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · More than one race
|
5 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
9 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
14 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of participants · Unknown or Not Reported
|
38 Participants
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
49 Participants
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
87 Participants
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of providers · American Indian or Alaska Native
|
0 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
0 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
0 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
|
|
Race (NIH/OMB)
Race of providers · Asian
|
1 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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2 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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3 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Race (NIH/OMB)
Race of providers · Native Hawaiian or Other Pacific Islander
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2 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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0 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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2 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Race (NIH/OMB)
Race of providers · Black or African American
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20 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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10 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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30 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Race (NIH/OMB)
Race of providers · White
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128 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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88 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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216 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Race (NIH/OMB)
Race of providers · More than one race
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6 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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0 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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6 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Race (NIH/OMB)
Race of providers · Unknown or Not Reported
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26 Participants
n=183 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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28 Participants
n=128 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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54 Participants
n=311 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Baseline Weight
Weight of participants
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83.6 Kg
n=166 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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79.7 Kg
n=143 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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81.4 Kg
n=309 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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Baseline Weight
Weight of providers
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78.02 Kg
n=161 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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76.66 Kg
n=114 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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77.11 Kg
n=275 Participants • As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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PRIMARY outcome
Timeframe: 24-monthsMother's body weight assessed by data collector
Outcome measures
| Measure |
Healthy Eating & Active Living Taught at Home
n=79 Participants
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
Healthy Eating \& Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
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Usual Care
n=62 Participants
Participants at usual care PAT sites will receive PAT as usual
Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
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Change in Weight
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-0.24 Kg
Standard Deviation 9.75
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0.49 Kg
Standard Deviation 11.87
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SECONDARY outcome
Timeframe: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomizedParent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure
Outcome measures
| Measure |
Healthy Eating & Active Living Taught at Home
n=88 Visit recordings
PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).
Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.
Healthy Eating \& Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an \~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
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Usual Care
Participants at usual care PAT sites will receive PAT as usual
Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
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Fidelity of Delivery to the Intervention
High
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67 Visit recordings
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—
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Fidelity of Delivery to the Intervention
Low
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12 Visit recordings
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—
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Fidelity of Delivery to the Intervention
Other/NA/Missing
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9 Visit recordings
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—
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Adverse Events
Healthy Eating & Active Living Taught at Home
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place