Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Chile
Sponsor:
Collaborators:
National Nutrition and Food Technology Institute
Pontifical University Catholic of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Ministry of Health, Chile
Information provided by (Responsible Party):
Ricardo Uauy, University of Chile
ClinicalTrials.gov Identifier:
NCT01916603
First received: July 4, 2013
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions in both mother and offspring. Weight gain during the first two years of life is also critical in defining the infant's predisposition to obesity during adulthood. Objective: to assess the effectiveness of delivering a primary health care intervention to enhance compliance with updated nutrition and health care (diet, physical activity and breastfeeding) standards from early pregnancy through the first year of life. Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). A cluster unit will be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to: enhanced nutrition and health care (intervention group) or routine nutrition and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the intervention PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical activity (PA) counseling-support based on updated recommendations and monitoring goals for weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. Expected results: participants in the intervention PHCCs will benefit by achieving adequate nutritional status & metabolic control, during and early after, pregnancy as well as adequate infant growth & development as a result of improved nutrition and health care practices. The results will likely be generalizable through the primary health care system; considering this is a "program effectiveness" trial conducted under "real life" conditions . Additionally, we will include specific ancillary mechanistic projects to better characterize the intervention and its impact.


Condition Intervention
Obesity
Weight Gain
Metabolic Diseases
Birth Weight
Infant Nutrition Disorders
Behavioral: Normative Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Normative Intervention (Diet, Physical Activity and Breastfeeding) on Maternal Nutrition and Offspring Growth and Development: Nutrition in the First 1000 Days Key to Healthy Growth and Long-term Health.

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Weight gain and nutritional status in mothers [ Time Frame: 36-40 weeks of gestation ] [ Designated as safety issue: Yes ]
  • Weight retention [ Time Frame: 12 months post-partum ] [ Designated as safety issue: Yes ]
  • Glycaemic control [ Time Frame: At 20-24 weeks of pregnancy ] [ Designated as safety issue: Yes ]
  • Lactation rates [ Time Frame: At 12 months post-partum ] [ Designated as safety issue: Yes ]
  • Initiation and duration of breastfeeding (exclusive and total) [ Time Frame: Birth-12 months ] [ Designated as safety issue: Yes ]
  • Weight, length and BMI growth in infants [ Time Frame: During the first year of life ] [ Designated as safety issue: Yes ]
  • Psychomotor development (based on abbreviated scale) [ Time Frame: During the first year of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implementation [ Time Frame: At 30 months into the recruitment ] [ Designated as safety issue: Yes ]
    Implementation: compliance to protocol by health personnel, midwives & dieticians per center, time allocated to the actions of the interventions, etc.

  • Participant compliance variables [ Time Frame: At 30 months into the recruitment ] [ Designated as safety issue: Yes ]
    Variables relate to the adoption by participants of the respective program activities: adherence to diet/physical activity prescriptions, adequate referral, attendance to dietician's clinic, lactation workshops, etc.


Estimated Enrollment: 2400
Study Start Date: September 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normative intervention
Normative intervention on diet & physical & breastfeeding: diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum
Behavioral: Normative Intervention
Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum
No Intervention: Routine care
Routine antenatal care according to national guidelines

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women seeking care before 15 weeks of pregnancy, residents within catchment area of selected Primary Health Care Centers, who are not planning to move in the next two years will be invited to participate in the study

Exclusion Criteria:

  • Pregnant women classified as high risk according to the norms of the Chilean Ministry of Health(MoH) and/or underweight (BMI<18.5)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916603

Contacts
Contact: Maria L Garmendia, PhD 56229781402 mgarmendia@inta.uchile.cl

Locations
Chile
Institute of Nutrition and Food Technology Not yet recruiting
Santiago, Región Metropolitana, Chile, 7830490
Contact: Maria L Garmendia, PhD    56224583539    mgarmendia@inta.uchile.cl   
Principal Investigator: Ricardo Uauy, PhD         
Sub-Investigator: Maria L Garmendia, PhD         
Sub-Investigator: Camila L Corvalán, PhD         
Sub-Investigator: Daniel V López de Romaña, PhD         
Sub-Investigator: Juan P Kusanovic, A.Professor         
Sub-Investigator: Karla A Silva         
Sub-Investigator: Michael Velten         
Sub-Investigator: Macarena Mayol         
Sub-Investigator: Paola C Casanello, PhD         
Sub-Investigator: María S López         
Sub-Investigator: Marcela A Araya, PhD         
Sponsors and Collaborators
University of Chile
National Nutrition and Food Technology Institute
Pontifical University Catholic of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Ministry of Health, Chile
Investigators
Principal Investigator: Ricardo Uauy, PhD University of Chile
  More Information

No publications provided

Responsible Party: Ricardo Uauy, Ph.D. Doctor in Philosophy, University of Chile
ClinicalTrials.gov Identifier: NCT01916603     History of Changes
Other Study ID Numbers: Fondecyt #1130277
Study First Received: July 4, 2013
Last Updated: August 1, 2013
Health Authority: Chile: Instituto de Salud Pública de Chile
Chile: Ministry of Health

Additional relevant MeSH terms:
Infant Nutrition Disorders
Nutrition Disorders
Malnutrition
Birth Weight
Metabolic Diseases
Obesity
Weight Gain
Body Weight
Signs and Symptoms
Overnutrition
Overweight
Body Weight Changes

ClinicalTrials.gov processed this record on September 14, 2014