Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
ConditionChildhood Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-36
SponsorUniversity of Houston
About this trial
The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents: Primary custodian (i.e., legal guardian) of a toddler, >18 years, have regular and frequent access to internet, fluent in English.
Toddlers: >/=18 and </=36 months of age, and walking.
Disqualifiers
Parents or toddlers who have mental or physical conditions that would prevent engagement in nutrition, physical activity, play, or instructional activities in a group setting or families unwilling to commit to the whole program (e.g., planning to move) will be excluded because participants may be randomly assigned to group interventions where engagement in these activities will be expected.
Parents who are not fluent in English will be excluded because this study was developed, and pilot tested on an English-speaking population. All study materials are in English, the interventions will be offered in English, and most of the surveys are not available or have been validated for non-English speaking audiences.
Parents who are not willing or able to participate in parent-toddler interaction assessments via Zoom will be excluded. This assessment is an important study variable.
Parents who are not willing to be recorded will be excluded because all Families Understanding Nutrition and Physically Active LIfestyles (FUNPALs) Playgroup sessions will be recorded for facilitator supervision purposes, and the parent-toddler interaction assessments will be recorded for later coding.
Trial design
Design model
Factorial
Treatments tested in this trial
Healthy Toddler Parent Group (HTPG)
BehavioralParent education class
Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup
BehavioralFamily playgroup
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Healthy Toddler Parent Group (HTPG)Active comparator 1 intervention
Group B: Usual LifestyleNo intervention 0 interventions
Group C: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) PlaygroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Weight Status
Weight-for-length (WFL) percentile for toddlers \<24 months. Length and weight measures will each be taken two times and averaged. Trained research assistants will measure height to the nearest 0.1 cm using a recumbent height board for children \<24 months. Weight will be measured to the nearest 0.1 kg using an electronic self-calibrating digital scale. For toddlers \<24 months, weight for length (WFL) will be calculated. Sex- and age-standardized WFL will be determined from Centers for Disease Control and Prevention (CDC) growth charts. Age and gender corrected WFL will be used to categorize weight status groups: \<5th percentile WFL will be considered underweight, 5th-84.99th percentile will be considered normal weight, \>85 percentile will be considered overweight and \>95 percentile will be considered obese per CDC guidelines.
Time frame
baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)2
Weight Status
Body mass index (BMI) percentile for toddlers \>/= 24 months. Height and weight measures will each be taken two times and averaged. Trained research assistants will measure height to the nearest 0.1 cm using a portable stadiometer for children \>/=24 months. Weight will be measured to the nearest 0.1 kg using an electronic self-calibrating digital scale. For toddlers \>/=24 months, BMI will be calculated. Sex- and age-standardized BMI percentiles will be determined from Centers for Disease Control and Prevention (CDC) growth charts. Age and gender corrected BMI percentile ranks will be used to categorize weight status groups: \<5th percentile BMI will be considered underweight, 5th-84.99th percentile will be considered normal weight, \>85 percentile will be considered overweight and \>95 percentile will be considered obese per CDC guidelines.
Time frame
baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)Secondary outcomes
1
Toddler Dietary Intake.
National Cancer Institute's (NCI's) Automated Self-Administered 24 hour dietary recall (ASA24)- Parents will be sent a link on 3 non-consecutive days via email and/or text within a 1-week period of time. The link will take them to a series of questions to assess what their child has eaten and drank in the last 24-hours. The ASA24 system provides a complete nutritional analysis of the diet including servings of food groups and amounts of micro and macronutrients consumed. The average number of servings of fruits, vegetables, and whole grain foods; grams of sugar; and grams of saturated fat will be retained for this study.
Time frame
baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)2
Toddler carotenoid (FV) intake.
Child fruit and vegetable (FV) consumption will be assessed using dermal reflectance spectrometry (Veggie Meter, Longevity Link Corp). Carotenoids are red, orange, and yellow fat-soluble pigments found in FV, and non-invasively measured dermal carotenoids are a valid and reliable proxy for intake of red, orange, yellow and dark green FV in adults and children. Per standard protocol under the direction of Nancy Moran, PhD (co-investigator) one finger from each child will be scanned using the Veggie Meter (Longevity Link Corp) to provide a linear score that represents dermal carotenoid intensity (0-850). Skin carotenoid levels can range from 0-850 with 3.9% standard deviation (SD). Two readings will be collected and if there is more than 33 units (1 SD based on normative data from manufacturer) difference, a third will be collected.
Time frame
baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)3
Activity
Accelerometers (GT3X+ Actigraph, Pensacola, FL). Following standard protocols for young children41,84,111,112, toddlers will wear the activity monitors for 8-consecutive days with the goal of obtaining at least 4 days of valid wear time. We had increased compliance with wear time by providing CareAline wraps to the families in our pilot study. These wraps are stretchy Velcro-fastened covers that are usually used to protect central line ports from toddlers' curious hands. Research staff will show parents directly how to place the actigraph on their child. Parents will receive an instruction guide to take home for reference and they will be encouraged to call research staff if they have any questions about it at home. Parents will be instructed to keep a detailed log of the child's activity when the child wears the actigraph to differential low count data (sleep vs non wear vs sedentary). Parents will be instructed to return the actigraph during the next measurement session.
Time frame
baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)Sponsors and contacts
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University of Houston
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Baylor College of Medicine
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov