Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Obesity

Pediatric Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Early responders will include those with targeted levels of fidelity by the October assessment. They will continue to receive low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).

This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to continue receiving low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).

This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to have high intensity support added (low intensity + holistic individualized facilitation, tailored educational materials).

5 implementation strategies: formal commitments, local champions, implementation blueprint , remind educators (cutting board with WISE EBPs), task-focused facilitation.

Low Intensity

Low intensity implementation strategies with the addition of holistic individualized facilitation and tailored educational materials.

High Intensity

Taren M Swindle, Ph.D.

Taren Swindle, PhD

"Together, We Inspire Smart Eating" (WISE) is an intervention that improves children's diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices, and (4) a mascot associated with fruits and vegetables. Standard implementation approaches to WISE result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs.

To date, most studies have employed an "all-or-nothing" approach, comparing multifaceted strategies to control groups without implementation support. Thus, there is an urgent need for optimized strategies that tailor implementation support intensity to the unique challenges and limited resources of the ECE context. The overall objectives of this application are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the EBPs of WISE while also examining implementation mechanisms. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes.

In the US, 4 out of 10 children are overweight or obese by age, and few children between 2 and 5 years old meet dietary guidelines. Consuming a healthy diet (e.g., fiber, antioxidant-rich foods) and maintaining a healthy weight protect against cancer and cancer-related mortality. Arkansas and Louisiana are among the states with the highest obesity rates, lowest quality diets, and highest cancer rates in the US. Given that early life patterns track into adulthood, early interventions are needed to decrease cancer risk later in life. Importantly, studies in early care and education (ECE, i.e., childcare) found that 80% of dietary programs and 70% of programs focusing on health behaviors demonstrated positive effects. Thus, ECE is a promising cancer prevention setting. However, intervention implementation in ECE is a challenge.

""Together, We Inspire Smart Eating" (WISE) is an intervention that improves children's diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices to support children's self-regulation, and (4) a mascot associated with fruits and vegetables. Prior work by the study team documented that standard implementation approaches to WISE (i.e., training and reminders only) result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs.

To date, few studies have compared implementation strategies to improve EBP uptake in ECE. Available studies have had a strong emphasis on policy, with results supporting the positive effect of multifaceted strategies. However, these studies often used an "all-or-nothing" approach, comparing costly multifaceted strategies to control groups with no implementation support. Knowledge is limited on the intensity of implementation strategies that are needed to yield success; some organizations may need more intense strategies than others. Thus, there is a critical need for optimized implementation strategies that tailor intensity (high vs. low) to the unique challenges and limited resources of ECE. Further, understanding how strategies work and for whom (i.e., implementation mechanisms) will advance implementation efforts in ECE.

The research team's foundational work (K01-DK110141) showed that a high-intensity implementation strategy package outperformed a standard implementation for WISE. However, it is likely not possible or necessary to provide a high-intensity strategy to all sites in wider dissemination. The proposed project will determine the optimal implementation intensity needed to improve the uptake of WISE EBPs in ECE. The overall objectives of this project are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the WISE EBPs while also examining moderators and mediators of response to the strategies. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes compared to the continuation of low-intensity strategies. The research team's long-term goal is to increase EBP implementation in the ECE setting to improve health outcomes for children. Thus, the following specific aims are proposed:

Specific Aim 1. Determine the effectiveness of an adaptive implementation strategy that tailors the intensity of implementation support versus a low-intensity strategy. Using an enhanced non-responder trial, we will compare the effect of continuing low-intensity strategies vs. augmenting with high-intensity strategies to implement WISE. Low-intensity includes task-focused facilitation aimed at leaders; high intensity includes holistic, individualized facilitation aimed at educators. Non-responder sites (N =64) will be randomized to continue with the low-intensity strategies or to add high-intensity strategies. The hypothesis is that, on average, sites receiving high-intensity strategies will outperform sites continuing the low-intensity strategies on the primary outcome of intervention fidelity and on secondary implementation and child health outcomes.

Specific Aim 2. Examine moderators and mediators of implementation outcomes in a mixed-methods design. For moderation, the hypothesis is that sites with weaker organizational readiness and less experienced educators will require high intensity strategies to reach fidelity. For mediation, the expectation is that educators' perceptions of barriers, implementation climate, and implementation leadership will mediate the effect of the strategies on implementation outcomes. Using an explanatory, sequential design, qualitative data at purposively selected sites (N =20) will be collected to identify emergent moderators and mediators.

Specific Aim 3. Assess the incremental cost-effectiveness of the adaptive implementation strategy. In this aim, cost per unit of fidelity associated with the adaptive implementation strategy will be estimated based on a meaningful difference in the research team's previously published fidelity measure. Results will also determine the incremental cost-effectiveness of applying the adaptive strategy compared to continuing low-intensity strategies for improving child health outcomes.

An enhanced non-responder trial design will be used to determine the effectiveness (Aim 1) and incremental cost-effectiveness (Aim 3) of an adaptive implementation strategy for WISE, while examining moderators and mediators of the strategy effect (Aim 2). In this trial, sites that do not respond to low-intensity strategies will be randomized to either (a) continue receiving low-intensity strategies or (b) receive high-intensity strategies. This design will determine the effect of an adaptive implementation strategy that adds high intensity versus one that continues with low intensity among non-responder sites.

Trained and field-reliable staff blinded to the study condition will collect data.

Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings

Testing an Adaptive Implementation Strategy to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings

After completion of the study, a database that includes de-identified participant information will be constructed, and this database will be accompanied by a detailed data dictionary that describes each variable by variable name, variable description, variable type (numeric, text, date), and acceptable variable ranges.

Fidelity to the WISE Evidence-Based Practices at the classroom level measured with the the WISE fidelity observational measure.

The measure includes 2 to 3 items per evidence-based practice (EBP) on a 1 (minimum) to 4 (maximum) scale to receive an average, continuous fidelity score with 4 representing the highest fidelity (i.e., higher scores reflect better fidelity). For each item, values are anchored to concrete, observable behaviors.

Louisiana Tech University

University of Arkansas

All participating families will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year.

Turtle Island Tales

Emily Tomayko, PhD

Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts.

Turtle Island Tales is an obesity prevention program for AI families with young children (3-8 years) that was developed to address the gap in home-based, family wellness programs for this population. Substantial research as been conducted on the effectiveness of this program for participating families. The primary aim of the current project is to investigate community-engaged dissemination to improve the reach of Turtle Island Tales. Dissemination strategies will be undertaken in partnership with community leaders and/or local Supplemental Nutrition Assistance Program Education (SNAP-Ed) agents who will disseminate the program through existing Extension/SNAP-Ed delivery mechanisms (SNAP-Ed is commonly administered through Extension programs of land-grant universities). Turtle Island Tales was accepted as a SNAP-Ed eligible program in 2022. As such, the program will be administered as part of usual/typical SNAP-Ed delivery in participating communities and largely constitutes program evaluation.

The primary research question is: What is the reach of the evidence-based Turtle Island Tales wellness program intervention within AI communities? A secondary aim for this project is determining the effectiveness of Turtle Island Tales among participating families using program evaluation survey data obtained via SNAP-Ed program evaluation.

Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year.

Reach Through Equitable Implementation of Turtle Island Tales

Reach Through Equitable Implementation of Turtle Island Tales in American Indian Communities: Program Effectiveness

Pre- and post-evaluation of effectiveness in behavioral outcomes including family-level questions targeting diet, physical activity, screen time, and sleep. The total score is used as the summary score, with a higher score indicating a more positive family home environment relative to health behaviors.

United States Department of Agriculture Household Food Insecurity 2-item screener: 1) "We worried whether our food would run out before we got money to buy more" and 2) "The food we bought just didn't last and we didn't have money to get more." An affirmative response ("Often True" or "Sometimes True") on either item is considered positive for food insecurity.

Two items from the validated Short Form-12 survey: 1) In the last month, how often have you felt that you were unable to control the important things in your life? and 2) In the last month, how often have you felt confident about your ability to handle your personal problems? Scores are summed, with a higher score being associated with more positive mental health status.

National Institutes of Health (NIH)

University of Utah

National Cancer Institute (NCI)

Montana State University

NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children).

The EUC condition (Brief NOURISH-T+) engages parents in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention.

NOURISH-T+ (Nourishing Our Understanding of Role Modeling to Improve Support and Healthy - Transitions) is a 6 session, psychoeducational program designed to teach parents of childhood cancer survivors with overweight/obesity knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

NOURISH-T+

Enhanced Usual Care (or Brief NOURISH-T+) is an abbreviated version of the full NOURISH-T+ intervention in which parents are engaged in a one-time information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

Brief NOURISH-T+

Marilyn Stern, PhD

Flandra Ismajli, BSW

Tung T Wynn, MD

Clancy B Stargel, MS

Winsome Thompson, PhD

Olena Ashworth

Andrew Galligan, MD

Jordan Marchak, PhD

Ebonee Harris

Kathy Ruble, PhD

Destiny Walker

Shalini Shenoy, MD

Kara Felts

Katharine R Lange, MD

Alexis Dompor

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population.

The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.

This project employs a cluster randomized, controlled, repeated measures trial study design, with parent-child dyads assigned to an evidence-informed manualized, social-cognitive parent intervention (NOURISH-T+) or to a comparison group (Enhanced Usual Care group - Brief NOURISH-T+). NOURISH-T+ stands for Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions.

Parents of pediatric cancer survivors (ages 5-14 years) with overweight and obesity, and off treatment for at least 6 months will be recruited across multiple pediatric oncology clinic sites. The University of South Florida (USF) serves as the coordinating data management and centralized research and intervention team and will also recruit eligible participants from its pediatric oncology clinic.

NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children).

Parents randomized to Brief NOURISH-T+ will participate in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention.

Outcome measures will be completed at baseline, 3-, 6-, and 12-months post-intervention.

NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors With Overweight/Obesity

Height and weight will be measured to obtain BMI z-score for gender and age.

Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time.

Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations.

Height and weight will be measured and used to calculate continuous adult BMI score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings	NCT05050539	Obesity, Childh... Nutrition Aspec...	Low Intensity High Intensity	3 Years -	University of Arkansas
Reach Through Equitable Implementation of Turtle Island Tales	NCT06298149	Obesity, Childh... Obesity Cancer	Turtle Island T...	18 Years -	Montana State University
Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings	NCT05050539	Obesity, Childh... Nutrition Aspec...	Low Intensity High Intensity	3 Years -	University of Arkansas
NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors	NCT04656496	Obesity, Childh... Cancer Survivorship	NOURISH-T+ Brief NOURISH-T...	5 Years - 14 Years	University of South Florida
Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings	NCT05050539	Obesity, Childh... Nutrition Aspec...	Low Intensity High Intensity	3 Years -	University of Arkansas
Reach Through Equitable Implementation of Turtle Island Tales	NCT06298149	Obesity, Childh... Obesity Cancer	Turtle Island T...	18 Years -	Montana State University
NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors	NCT04656496	Obesity, Childh... Cancer Survivorship	NOURISH-T+ Brief NOURISH-T...	5 Years - 14 Years	University of South Florida

Spots Global Cancer Trial Database for obesity, childhood