Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early
Kalyanaraman Kumaran1,2, Ghattu V Krishnaveni2, Kumar Gavali Suryanarayana3,4
1Epidemiology Research Unit, CSI Holdsworth Memorial Hospital, Mysore, Karnataka, India kk@mrc.soton.ac.uk.
Insights
This study investigates an integrated intervention for pregnant women to reduce non-communicable disease risk in children. The Healthy Life Trajectories Initiative aims to improve child health through preconception and pregnancy support.
Area of Science:
- Public Health
- Epidemiology
- Child Health
Background:
- Non-communicable diseases (NCDs) pose a significant global health burden, with origins often established in early life.
- Early life interventions, including preconception and pregnancy, are crucial for mitigating long-term NCD risk.
- The Healthy Life Trajectories Initiative is an international effort to address NCDs through integrated, early-life interventions.
Purpose of the Study:
- To describe the protocol for the India-based study within the Healthy Life Trajectories Initiative.
- To evaluate the effectiveness of a multifaceted intervention initiated preconceptionally on reducing NCD risk in children.
- To assess the impact of optimized nutrition, parenting support, lifestyle changes, and environmental toxin reduction on child health outcomes.
Main Methods:
- A village-based cluster randomized trial involving approximately 6000 married women in rural Mysore.
- Three arms: preconception intervention, pregnancy intervention, and control.
- Intervention components include nutrition optimization, parenting programs with cognitive-behavioral therapy, lifestyle behavior change support, and reduction of indoor air pollution.
Main Results:
- Primary outcome: adiposity in children at age 5 years, measured by fat mass index.
- Collection of extensive biospecimens from mothers and offspring for intermediate outcome analysis.
- Intention-to-treat analysis will be employed to assess intervention effects.
Conclusions:
- The study protocol is designed to provide robust evidence on the long-term impact of early-life interventions on NCD risk.
- Process and economic evaluations will inform scalability and public health translation of the intervention.
- Findings will be disseminated through peer-reviewed publications, policy maker engagement, and community outreach.
Introduction:
The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.
Methods And Analysis:
The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive-behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.
Ethics And Dissemination:
The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.
Trial Registration Number:
ISRCTN20161479, CTRI/2020/12/030134; Pre-results.
Related Concept Videos
01:20Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
01:30Community Based Intervention
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
01:13Randomized Experiments
Simple randomization
Simple...
01:11Clinical Trials: Overview
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:15Study Design in Statistics
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...