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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01916603
• Other study ID #: Fondecyt #1130277
• Status: Not yet recruiting
• Phase: N/A
• First received: July 4, 2013
• Last updated: August 1, 2013
• Start date: September 2013
• Est. completion date: March 2017

Study information

• Verified date: July 2013
• Source: University of Chile
• Contact: Maria L Garmendia, PhD
• Phone: 56229781402
• Email: mgarmendia[@]inta.uchile.cl
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de ChileChile: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Introduction: in Chile as well as in most of the world, obesity and related chronic diseases (cardiovascular diseases, cancer and diabetes (NCDs)) are presently the main causes of death and disability. Although these conditions are observed mostly in adulthood, there is now considerable evidence that indicates that they are rooted in the first 1000 days of life (from -1 to + 2yrs of life).

Several studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions for both mother and offspring. Weight gain during the first two years of life is also critical, not only to ensure infant survival, but also in defining the infant's predisposition to the emergence of chronic diseases during adulthood. From a population perspective, the most effective approach to counteract the epidemic of obesity and NCDs is to prevent them. Recommendations for healthy diets and physical activity during pregnancy and infancy, as well as monitoring of nutrition goals are currently available in the Chilean primary health care system. However, most of these recommendations are not up to date and virtually all are poorly implemented. Objective: to assess the effectiveness of delivering (via primary health centers) an intervention that enhances compliance with up to date nutrition and health care standards (regarding diet, physical activity and breastfeeding promotion) during pregnancy and the first year of life. The main goal is that mothers achieve adequate nutritional status & metabolic control, during and early after pregnancy, and that infants grow and develop healthily (adequate linear and ponderal growth according to WHO standard, while avoiding excess BMI gains) Methods: this is a cluster randomized controlled trial (CRCT), designed as a public health "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). The cluster units will be 12 primary health care centers (PHCC) in South-East Santiago randomly allocated to: 1) enhanced nutrition and health care standards (intervention group) or 2) routine care (control group).

Women seeking care before 15 weeks of pregnancy, residents within a catchment area of selected PHCCs, who are not planning to move in the next two years will be invited to participate in the study. Pregnant women classified as high risk according to the norms of the Chilean Ministry of Health (MoH)and/or underweight (BMI<18.5) will be excluded. We will recruit 200 women in each PHCC and assuming a 20% loss to f-up we will end with 960 women per arm of the study. 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 months postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. The outcomes will be: 1)achievement of adequate nutritional status & metabolic control during pregnancy: a. Weight gain according to Institute of Medicine (IOM) recommendations, b. glycemic control based on ADA 2011 recommendations, 3. No weight retention at 12 months, and 2) healthy infant growth and development: a) height and BMI growth based on WHO standards, b) normal abbreviated psychomotor development test (TEPSI) and evaluation scale of psychomotor development (EEDP) at 12 months. Mothers & infants will be monitored to ensure the safety of the intervention (assessment of undernutrition, micronutrient deficiency and indices of poor nutrition). Data will be collected as part of routine health care activities and analyzed based on the allocation to each study group ("intention to treat"). Results will be presented as appropriate effect sizes with a measure of precision (95% confidence intervals). Further exploratory analyses will be based on those participants that fully follow the protocol ("per-protocol analyses"). Expected results: we expect that the intervention will benefit the participants in achieving adequate nutritional status & metabolic control, during and early after, pregnancy as well as adequate infant growth & development as a result of an increase in the impact of standard nutrition and health care practices. The results should be potentially extended to the rest of the primary health care system given the "program effectiveness" approach that will be taken. Additionally, we expect that this study will serve as a core project in which other ancillary projects will be nested. Gathered information should contribute to a better understanding of how to develop effective interventions to halt the maternal and obesity epidemic and its associated co-morbidities in the Chilean population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2400
• Est. completion date: March 2017
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Infant Nutrition Disorders
• Metabolic Diseases
• Nutrition Disorders
• Obesity
• Weight Gain

Intervention

Behavioral:
• Normative Intervention
Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum

Locations

Country	Name	City	State
Chile	Institute of Nutrition and Food Technology	Santiago	Región Metropolitana

Sponsors (5)

Lead Sponsor	Collaborator
University of Chile	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, Ministry of Health, Chile, National Nutrition and Food Technology Institute, Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain and nutritional status in mothers		36-40 weeks of gestation	Yes
Primary	Weight retention		12 months post-partum	Yes
Primary	Glycaemic control		At 20-24 weeks of pregnancy	Yes
Primary	Lactation rates		At 12 months post-partum	Yes
Primary	Initiation and duration of breastfeeding (exclusive and total)		Birth-12 months	Yes
Primary	Weight, length and BMI growth in infants		During the first year of life	Yes
Primary	Psychomotor development (based on abbreviated scale)		During the first year of life	Yes
Secondary	Implementation	Implementation: compliance to protocol by health personnel, midwives & dieticians per center, time allocated to the actions of the interventions, etc.	At 30 months into the recruitment	Yes
Secondary	Participant compliance variables	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.	At 30 months into the recruitment	Yes