Condition category
Haematological Disorders
Date applied
19/03/2013
Date assigned
15/04/2013
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There are high rates of iron deficiency anemia (IDA) among babies in China’s rural areas, but since no single institution holds responsibility for the health and development of this critical age group, IDA and other undernutrition problems are commonly neglected. We have two objectives in this study. Our first objective is to measure the impact of providing a daily nutritional supplement packet with iron on the health and development of babies in our study. Our second objective is to compare how well two programs designed to encourage usage of the nutritional supplement packets work: one program in which the packets are simply given away for free, and another in which caregivers are offered a conditional cash transfer for using the packets.

Who can participate?
All babies in 189 villages in poor parts of rural Shaanxi Province (China), aged 6-12 months at the time of participation.
What does the study involve?
Villages will be randomly allocated to one of three groups: (1) a Control Group with no intervention; (2) a Free Supplement Group that receives nutritional training for caregivers and free daily nutritional supplements for babies; (3) a Text Messaging Group that receives the same interventions as the Free Supplement Group plus a daily text message reminding them to feed their baby the nutritional packet. These text message reminders will continue for the entire duration of the study (24 months).
What are the possible benefits and risks of participating?
The risks to the participants are lo. There is no risk of harm from the nutritional supplements. Participating babies may experience some discomfort during the hemoglobin blood test, but since the test only requires a few drops of blood taken using new and sterilized equipment, the risk of infection is minimal.

Where is the study run from?
189 villages in Shaanxi Province (China)

When is the study starting and how long is it expected to run for?
May 2013 to May 2015.

Who is funding the study?
Funding for the project is provided by the International Initiative for Impact Evaluation (3ie), the UBS Foundation, the Bank of East Asia, the Heinz Institute of Nutritional Sciences (HINS), and the Shanghai Charity Foundation.

Who is the main contact?
Ms Alexis Medina
amedina5@stanford.edu

Trial website

Contact information

Type

Scientific

Primary contact

Prof Scott Rozelle

ORCID ID

Contact details

616 Serra Street
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nourishing the future: targeting infants and their caregivers to reduce undernutrition in rural China - a cluster-randomized controlled trial

Acronym

Study hypothesis

We focus on the undernutrition problem of iron deficiency anemia (IDA). Iron deficiency anemia is the most common nutritional deficiency worldwide, affecting approximately a quarter of the global population, mostly in developing countries. Prolonged iron deficiency impairs the production of hemoglobin, limiting the amount of oxygen that blood cells can carry to essential organs and, most importantly, to the brain. As a result, IDA can cause fatigue, poor attention, and prolonged physical impairment. A large body of literature also links iron deficiency – with or without anemia – to impaired cognition and brain function. Iron deficient school-age children have been shown to have worse educational outcomes, including grades, attendance and attainment, than their better-nourished peers.

1. What is the impact on child health and development of offering caregivers a free daily
nutrition supplement packet for their child?
2. What is the uptake rate of the nutrition supplements when caregivers are educated about
nutrition and given the supplements free of charge?
3. How does the uptake rate of the nutrition supplements change when caregivers are sent a daily text message reminding them to feed the supplements to their babies?

Ethics approval

Stanford University Human Subjects Research Institutional Review Board approved on
26/10/2012 (ref: 25734)

Study design

Cluster randomised single-blind controlled interventional multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Iron deficiency anemia

Intervention

Control Group: No intervention.
Treatment Group 1: Free Supplement Arm
Families in the Free Supplement Arm will receive the following interventions:
- An in-depth nutritional training campaign, teaching caregivers (mothers, grandmothers and others) the importance of good infant nutrition, providing examples of a balanced diet, and informing about the role of nutritional supplements
- A nutritional supplementation program, in which families participating in the project will be offered free NurtureMate supplement packets

Treatment Group 2: Text Messaging Arm
Families in the Text Messaging Arm will receive the same two interventions as the Free Supplement Arm, and also:
- All caregivers will be will be sent a daily text message reminding them to feed their baby the nutritional supplement

All treatments will last for 24 months, from May 2013 through May 2015.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Hemoglobin level, measured every 6 months using HemoCue 201+ fingerprick technology
Height and weight, measured every 6 months using WHO standard methodology
Cognitive development, as measured by Bayley Scale of Infant Development (BSID) III test
Packet uptake rate, as measured by monthly counts of empty nutritional packets and bi-annual List Randomization Technique (LRT) survey questions (to determine whether the caregiver respondent is lying about the number of packets fed to the infant participant)

Secondary outcome measures

Infant health, as measured by a monthly survey of episodes of illness
Infant social emotional development, as measured by the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Caregiver nutritional knowledge, as measured by a nutritional quiz administered every six months over the course of the study

Overall trial start date

01/04/2013

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All babies aged 6-12 months (at the start of the study) in the sample areas in rural Shaanxi
Province.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

1,890

Participant exclusion criteria

Babies outside of our age range (6-12 months) at the start of the study will not be included in the study.

Recruitment start date

01/04/2013

Recruitment end date

01/05/2015

Locations

Countries of recruitment

China

Trial participating centre

616 Serra Street
Stanford
94305
United States of America

Sponsor information

Organisation

Rural Education Action Program (REAP) (USA)

Sponsor details

616 Serra Street
Stanford
94305
United States of America

Sponsor type

Research organisation

Website

http://www.reapchina.org/

Funders

Funder type

Charity

Funder name

International Initiative for Impact Evaluation (3ie)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UBS Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bank of East Asia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Heinz Institute of Nutritional Sciences (HINS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Shanghai Charity Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes