Prevention of Overweight in Infancy (POInz)

University of Otago

Status: Completed

Conditions: Obesity; Growth; Sleep

Treatments: Behavioral: FAB; Behavioral: Sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT00892983

105891.01.P.NH

HRC 08/374 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.

Full description

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

1. That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television 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.
2. 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.
3. That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
4. That intervention 2 will lead to lower rates of maternal depression and increased family well being.

Enrollment: 802 patients

Sex: All

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mothers booked for delivery in Dunedin, 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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802 participants in 4 patient groups

Standard well child care

No Intervention group

Description:

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.

Food Activity Breast feeding support

Experimental group

Description:

FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity

Treatment:

Behavioral: FAB

Sleep

Experimental group

Description:

Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months

Treatment:

Behavioral: Sleep

FAB + Sleep

Experimental group

Description:

combination of interventions used in arms 2 and 3

Treatment:

Behavioral: Sleep

Behavioral: FAB