Clinical trial NCT05656807: Evaluation of Child Care Staff Weight Management Program
Official title: My Weight-their Weight: eHealth Intervention for Managing Obesity in Child Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: child care centers
child care provider health
nutrition
physical activity
body weight
behavior change
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-12-19
Enrollment: 924
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment.

The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children.

Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support.

Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.

Detailed description: This study is a two-group clustered randomized trial to evaluate if improving child care providers' health behaviors elicit meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The investigators will randomize (by center, 1:1 ratio) 84 child care centers, 168 child care providers, and 672 children from these centers to one of two groups (standard Go NAPSACC or Go NAPSACC enhanced) for a 12 month trial (6 months provider weight loss; 6 months no contact follow-up). The specific aims are to 1) improve dietary quality and physical activity behaviors of 2-5-year-old children. 2) improve weight and weight related behaviors (dietary intake and physical activity) of child care providers, and 3) improve the nutrition and physical activity environments at child care centers. Participants randomized to standard Go NAPSACC will receive support for center wide changes focusing on engaging center directors and orienting them to Go NAPSACC, given access to interactive online tools that guide change, and providing ongoing support as they work to adopt evidence-based healthy weight practices. Participants randomized to Go NAPSACC enhanced will receive the traditional Go NAPSACC program (previously described); in addition, child care providers will receive a weight management intervention. The weight management intervention will be guided by social cognitive theory and integrate techniques known to be most effective for changing diet and physical activity behaviors, including intention formation, goal setting (≥5% weight loss at 6 mos. and no regain at 12 mos.), self-monitoring (diet, physical activity, weight), and feedback. Participants will receive a progressive physical activity program. The physical activity program (walking, jogging, biking, etc.) will be progressive and prescribed at a moderate intensity as recommended the "Physical Activity Guidelines for Americans" of 150 min/wk. Starting active minutes goal will be based on self-reported current activity levels: 0 min/wk = 10 min/day goal; 1-59 min/wk = 15/min/day goal, \>60 min/wk = 20 min/day goal. The reduced energy diet will follow the Stop Light Diet approach which categorizes foods by energy content: green (low energy: consume freely), yellow (moderate energy: consume in moderation) and red (high energy: consume sparingly). Starting weight will be used to suggest tailored red food limits: Weight Loss - \<250lbs = 3; 250 - \<300 = 4; \>300 = 5. Weight Maintenance - \<250 = 4; 250 - \<300 = 5; \>300 = 6. The stop light diet approach is suitable for all participants (including for whom weight loss may not be recommended \[e.g., BMI \<25 kg/m2\] as it does not specifically prescribe a calorie deficit but focuses on improvement of diet quality.The effectiveness of the intervention will be evaluated by comparing differences between the Go NAPSACC enhanced and standard Go NAPSACC control groups in child's physical activity and diet quality at 6 mos. (primary outcomes). Primary and secondary aims will be analyzed using maximum likelihood methods. Multi-level linear mixed models with repeated measures will be used to estimate change at 6 and 12 mos. and to test for statistical differences across groups in changes over time. Models will include random effect for cluster to account for covariance between participants within the same center as well as fixed effects for time, trial arm, time\*arm interaction. To further explore the effect of the intervention, these analyses will be followed by sensitivity analyses that adjust for baseline variables distributed differently between intervention groups and examine completers only. Secondary outcomes will also be examined as longitudinal covariates and asses their association with longitudinal measures of primary outcomes, controlling for treatment, at 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

Child Care Centers:

* Be open year-round
* Licensed with no plans to close in the next 2 years
* Been in operation for at least 1 year
* Have at least two classrooms serving children 2-5 years-old
* Serve at least lunch to the 2-5-year old children
* Have no history of Go NAPSACC participation in the past 6 months
* Two 2-5-year-old classroom providers and 4 parents from each classroom must provide consent to participate in the study

Child Care Providers (Directors and Teachers):

* Ability to provide informed consent.
* Age 18 years or older.
* Teacher only: Be a teacher in a 2-5-year-old classroom.
* Teacher only: Not pregnant, nor planning to become pregnant in the next year

Children:

* Be in a classroom with a participating child care teacher.
* Be 2-5 years old.
* The consenting primary caregiver must be able to read English

Exclusion Criteria:

Child Care Centers:

* Serve only non-English speaking families

Primary outcomes:
measure: Change in Children's Diet Quality at Child Care from Baseline to 6 months
timeFrame: Baseline and 6 months post-intervention
measure: Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months
timeFrame: Baseline and 6 months post-intervention
Secondary outcomes:
measure: Change in Children's Diet Quality at Child Care from 6 to 12 months
timeFrame: 6 months post-intervention and 12 months post-intervention
measure: Change in Children's Non-sedentary Time at Child Care from 6 to 12 Months
timeFrame: 6 months post-intervention and 12 months post-intervention
measure: Change in Child Care Providers Diet Quality
timeFrame: Baseline through 12 months post intervention
measure: Change in Child Care Providers Physical Activity
timeFrame: Baseline through 12 months post intervention
measure: Change in Child Care Providers weight
timeFrame: Baseline through 12 months post intervention
measure: Change in Nutrition Environment Score
timeFrame: Baseline through 12 months post intervention
measure: Change in Physical Activity Environment Score
timeFrame: Baseline through 12 months post intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Health Promotion and Disease Prevention
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erik Willis, PhD
role: PRINCIPAL_INVESTIGATOR
References: