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Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Lomaira | Active Comparator | Participants will receive Lomaira 8mg for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal. |
|
| Placebo | No Intervention | Participants will receive Placebo for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lomaira 8Mg Tablet | Drug | 8 mg tablet up to three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change between baseline visit and final study visit at week 37 |
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Inclusion Criteria: Adults
Exclusion Criteria: Adult
Inclusion Criteria: (Toddler)
Exclusion Criteria (Toddler)
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| Name | Affiliation | Role |
|---|---|---|
| Warren C Peters, MD | Loma Linda University (School of Public Health) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States | ||
| Nutrition Research Center |
No formal plans
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Loma Linda |
| California |
| 92350 |
| United States |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |