The purpose of this study is to treat toddler obesity by improving the toddler nutritional environment. Parents will participate in a free internet nutrition program and may also take obesity medication. These measures may improve the parental nutritional environment and in turn, improve the toddler nutritional environment as well.
Fifty parent or caregiver and toddler teams will be enrolled in a 37 week study in which the parents or caregivers will be randomized to receive either an obesity drug or a placebo, while simultaneously enrolled in the Full Plate Living lifestyle program. Study eligibility and ongoing participation will be assessed by lab results, biometric measurements and nutrition questionnaires to monitor the impact of diet and medication on the parental dietary environment. Toddler body mass index (BMI) will be calculated at study inception and completion to assess potential impact on the toddler dietary environment. Teaching will be provided to parents on healthy dietary choices, adequate sleep and stress control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
8 mg tablet up to three times a day
Loma Linda University
Loma Linda, California, United States
Nutrition Research Center
Loma Linda, California, United States
Change in Toddler's Body Mass index (BMI) percentile at week 37
Toddler BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.
Time frame: Change between baseline visit and final study visit at week 37
Change in parent's Body Mass index (BMI) at week 37
Adults BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.
Time frame: Change between baseline visit and final study visit at week 37
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