Prevention of Overweight in Infancy - Full Text View

Sponsored by:	University of Otago
Information provided by:	University of Otago
ClinicalTrials.gov Identifier:	NCT00892983

Purpose

Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

Condition	Intervention
Obesity Growth Sleep	Behavioral: FAB Behavioral: Sleep

MedlinePlus related topics: Breast Feeding Depression Obesity Obesity in Children Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial

Further study details as provided by University of Otago:

Primary Outcome Measures:

Anthropometric measures - weight velocity 0 - 12 months, 12 - 24 months and 24 to 36 months as well as BMI z score and abdominal circumference at 24 and 36 months. [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Energy and nutrient content of diet [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Amount of small screen viewing [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Major/ Moderate sleep problems [ Time Frame: 4,6,12,24 and 36 months ] [ Designated as safety issue: No ]
Physical activity (using actical accelerometry over 5 days) [ Time Frame: 24 and 36 months ] [ Designated as safety issue: No ]
Duration of exclusive and any breast feeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Parental depression score [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Duration of sleep [ Time Frame: 4,6,12, 24 and 36 months ] [ Designated as safety issue: No ]
Number of night awakenings [ Time Frame: 4,6, 12, 24 and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard well child care: No Intervention Standard Well Child Care (SWCC) - 8 Core visits at 2-4 weeks, 6 weeks, 3, 5, 8-10 and 15 months, 2 and 3 years.
FAB (Food Activity Breast feeding support): Experimental 8 extra parent contacts for augmented education and support around breast feeding, food and activity	Behavioral: FAB Standard well child care plus 8 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, 3-4, 6, 12, 15, 18, and 21 months post-partum.
Sleep: Experimental Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months	Behavioral: Sleep Standard well child care plus 5 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), sleep problem prevention starting at 3 weeks and then sleep problem intervention starting at 6 months or if problems emerge upto 2 years of age. Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months. Intervention after 6 months uses preferentially a technique called "parental presence", and if this does not fit family a technique called "camping out" and finally, if neither of the first two fit family, controlled crying.
FAB + Sleep: Experimental combination of interventions used in arms 2 and 3	Behavioral: FAB Standard well child care plus 8 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, 3-4, 6, 12, 15, 18, and 21 months post-partum. Behavioral: Sleep Standard well child care plus 5 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), sleep problem prevention starting at 3 weeks and then sleep problem intervention starting at 6 months or if problems emerge upto 2 years of age. Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months. Intervention after 6 months uses preferentially a technique called "parental presence", and if this does not fit family a technique called "camping out" and finally, if neither of the first two fit family, controlled crying.

Detailed Description:

We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:

That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding TV watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood.
That anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain.
That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
That intervention 2 will lead to lower rates of maternal depression and increased family well being.

Eligibility

Ages Eligible for Study:	15 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Mothers booked for delivery in Dunedin or Invercargill, New Zealand

Exclusion Criteria:

Women booked after 34 weeks gestation,
Identified congenital abnormality likely to affect feeding and/or growth
Home address outside of metropolitan Dunedin or Invercargill,
Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
Unable to communicate in English or te reo Maori.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892983

Contacts

Contact: Barry J Taylor, FRACP	64 3 4740 999 ext 8222	barry.taylor@otago.ac.nz
Contact: Rachael Taylor, PhD	64 3 4795262	rachael.taylor@otago.ac.nz

Locations

New Zealand, South Island
University of Otago	Recruiting
Dunedin, South Island, New Zealand, 9013
Contact: Barry Taylor 64 3 4640 489

Sponsors and Collaborators

University of Otago

Investigators

Principal Investigator:	Barry J Taylor, FRACP	University of Otago
Principal Investigator:	Rachael Taylor, PhD	University of Otago

More Information

Additional Information:

University of Otago This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Otago ( Professor Barry J Taylor )
Study ID Numbers:	105891.01.P.NH, HRC 08/374
Study First Received:	May 3, 2009
Last Updated:	May 3, 2009
ClinicalTrials.gov Identifier:	NCT00892983 History of Changes
Health Authority:	New Zealand: Health Research Council

Keywords provided by University of Otago:

Obesity
Sleep
Physical activity
Breast feeding
Depression

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Depression
Nutrition Disorders

Overnutrition
Overweight
Depressive Disorder
Weight Gain

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009