Obesity
Conditions
Brief summary
This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.
Detailed description
Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period women tend to gain disproportionally large amounts of weight compared to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced waist circumference was developed in partnership with Parents as Teachers (PAT), a national home visiting, community based organization with significant reach in this population. PAT provides parent-child education and services free-of-charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. This study will extend these findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact. The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the US (N= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing PAT sites (20 HEALTH, 20 usual care) will receive the HEALTH training curriculum through the PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation research will characterize determinants that influence HEALTH dissemination and implementation at three levels: mother, parent educator, PAT site to enhance external validity (reach and maintenance) and population level impact. The findings from this innovative study will have significant potential to help reverse the trend of excessive weight gain among young adult women, a critical priority target in battling the epidemics of obesity and chronic disease, by reaching women with an evidence-based intervention nation-wide.
Interventions
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.
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.
Sponsors
Study design
Intervention model description
Healthy Eating & Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
Eligibility
Inclusion criteria
For Parent educators: Inclusion Criteria: * Deliver PAT at a site participating in the study * Provide informed consent
Exclusion criteria
* At least 18 years of age For Participants: Inclusion Criteria: * 18-45 years of age * overweight or obese (BMI 25-45 kg/m2) * English or Spanish speaking * participating or willing to participate in PAT at a participating PAT site for 2 years * able to give informed consent for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 24-months | Mother's body weight assessed by data collector |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity of Delivery to the Intervention | throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized | Parent 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 349 |
| 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. | 271 |
| Total | 620 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 60 | 54 |
| Overall Study | Pregnancy | 17 | 25 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Providers not included in the primary outcome. | 183 | 128 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Healthy Eating & Active Living Taught at Home | Total |
|---|---|---|---|
| Age, Continuous Age of participant | 31.2 Years STANDARD_DEVIATION 6.1 | 30.3 Years STANDARD_DEVIATION 5.6 | 30.7 Years STANDARD_DEVIATION 5.8 |
| Age, Continuous Age of provider | 40.11 Years STANDARD_DEVIATION 12.04 | 39.75 Years STANDARD_DEVIATION 12.05 | 39.93 Years STANDARD_DEVIATION 12.05 |
| Baseline Weight Weight of participants | 79.7 Kg | 83.6 Kg | 81.4 Kg |
| Baseline Weight Weight of providers | 76.66 Kg | 78.02 Kg | 77.11 Kg |
| Ethnicity (NIH/OMB) Ethnicity of participant Hispanic or Latino | 62 Participants | 68 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Ethnicity of participant Not Hispanic or Latino | 67 Participants | 89 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Ethnicity of participant Unknown or Not Reported | 14 Participants | 9 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Ethnicity of provider Hispanic or Latino | 36 Participants | 58 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Ethnicity of provider Not Hispanic or Latino | 80 Participants | 114 Participants | 194 Participants |
| Ethnicity (NIH/OMB) Ethnicity of provider Unknown or Not Reported | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) Race of participants American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Race of participants Asian | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Race of participants Black or African American | 15 Participants | 25 Participants | 40 Participants |
| Race (NIH/OMB) Race of participants More than one race | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) Race of participants Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Race of participants Unknown or Not Reported | 49 Participants | 38 Participants | 87 Participants |
| Race (NIH/OMB) Race of participants White | 66 Participants | 93 Participants | 159 Participants |
| Race (NIH/OMB) Race of providers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race of providers Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Race of providers Black or African American | 10 Participants | 20 Participants | 30 Participants |
| Race (NIH/OMB) Race of providers More than one race | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Race of providers Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Race of providers Unknown or Not Reported | 28 Participants | 26 Participants | 54 Participants |
| Race (NIH/OMB) Race of providers White | 88 Participants | 128 Participants | 216 Participants |
| Sex: Female, Male Sex of participant Female | 143 Participants | 166 Participants | 309 Participants |
| Sex: Female, Male Sex of participant Male | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Sex of provider Female | 128 Participants | 182 Participants | 310 Participants |
| Sex: Female, Male Sex of provider Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 349 | 0 / 271 |
| other Total, other adverse events | 0 / 349 | 0 / 271 |
| serious Total, serious adverse events | 0 / 349 | 0 / 271 |
Outcome results
Change in Weight
Mother's body weight assessed by data collector
Time frame: 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Eating & Active Living Taught at Home | Change in Weight | -0.24 Kg | Standard Deviation 9.75 |
| Usual Care | Change in Weight | 0.49 Kg | Standard Deviation 11.87 |
Fidelity of Delivery to the Intervention
Parent 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
Time frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Healthy Eating & Active Living Taught at Home | Fidelity of Delivery to the Intervention | High | 67 Visit recordings |
| Healthy Eating & Active Living Taught at Home | Fidelity of Delivery to the Intervention | Low | 12 Visit recordings |
| Healthy Eating & Active Living Taught at Home | Fidelity of Delivery to the Intervention | Other/NA/Missing | 9 Visit recordings |