Starting Early Obesity Prevention Program
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| ClinicalTrials.gov Identifier: NCT01541761 |
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Recruitment Status :
Active, not recruiting
First Posted : March 1, 2012
Last Update Posted : February 14, 2022
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The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.
The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.
Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Childhood Obesity | Behavioral: Family groups | Not Applicable |
Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.
Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 238 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | RCT Testing the Effectiveness of an Early Obesity Prevention Program |
| Actual Study Start Date : | April 2012 |
| Estimated Primary Completion Date : | October 30, 2022 |
| Estimated Study Completion Date : | October 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Family groups
Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic.
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Behavioral: Family groups
The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting. |
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No Intervention: Standard care
Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.
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- Reduction in the prevalence and degree of obesity at age 3 years [ Time Frame: 3 years ]Continuous and dichotomized measures (BMI percentiles)
- Improvement in infant diet composition [ Time Frame: 1-3 years ]
Diets of intervention group infants and children will be more likely to follow recommended guidelines including:
i) Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes
- Improvement in infant lifestyle behaviors associated with increased risk of obesity. [ Time Frame: 1-3 years ]
Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including:
i) Better sleep habits ii) Reduced screen time iii) Increased physical activity
- Improvement in parent feeding knowledge, attitudes, styles and practices [ Time Frame: 1-3 years ]
Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including:
i) Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style
- Reduction in infant and child excess weight gain [ Time Frame: 1-3 years ]Continuous anthropometric measures (weight for length z-scores)
- Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention [ Time Frame: 2-5 years ]Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors
- Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention [ Time Frame: 2-5 years ]Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain
- Feasibility process measures: [ Time Frame: 2-5 years ]Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.
- Participant engagement [ Time Frame: 2-5 years ]Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure
- Participant satisfaction [ Time Frame: 2-5 years ]We will assess program satisfaction
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Latina mother > 18 years with singleton uncomplicated pregnancy
- Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
- Mother to be primary caregiver of child
- Mother speaks fluent English or Spanish
Exclusion Criteria:
- Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
- Family does not have a phone
- Infants with severe medical problems that may affect feeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541761
| United States, New York | |
| Bellevue Hospital Center Ambulatory Care Clinic | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Mary Jo Messito, MD | NYU School of Medicine | |
| Principal Investigator: | Rachel Gross, MD MS | Children's Hospital at Montefiore |
| Responsible Party: | NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT01541761 |
| Other Study ID Numbers: |
10-02175 |
| First Posted: | March 1, 2012 Key Record Dates |
| Last Update Posted: | February 14, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Obesity Child Hispanic |
Prevention Nutrition Parenting |
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Obesity Pediatric Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight |