First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial

NCT ID: NCT01084109

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-07-31

Brief Summary

The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.

Detailed Description

Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages. Participants from four sites in the Global Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; as necessary the food intervention and messages will be delivered at home by the assigned community coordinator or alternate. Outcome measures, obtained by a separate group of local, trained assessment workers, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.

Conditions

Complementary Feeding; Infant Growth

Keywords

Complementary feeding; Infant growth; Developing countries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)

Group Type: ACTIVE_COMPARATOR

Lyophilized meat

Intervention Type: OTHER

Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)

2

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

Group Type: ACTIVE_COMPARATOR

Cereal

Intervention Type: OTHER

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

Interventions

Lyophilized meat

Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)

Intervention Type: OTHER

Cereal

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Infant aged 3-4 months;
• Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.

Exclusion Criteria

1. known congenital anomaly;

2. infant of multiple births;

3. known neurological deficit apparent at the time of enrollment (including seizures).

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kinshasa School of Public Health

OTHER

Sponsor Role: collaborator

University of Zambia

OTHER

Sponsor Role: collaborator

INCAP, Chiimaltenango, Guatemala

UNKNOWN

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

NICHD Global Network for Women's and Children's Health

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute for Nutrition of Central America and Panama (INCAP)

Chiimaltenango, , Guatemala

Agha Khan University

Karachi, , Pakistan

Kinshasa School of Public Health

Karawa, , Republic of the Congo

University of Zambia

Lusaka, , Zambia

Countries

Guatemala; Pakistan; Republic of the Congo; Zambia

References

Manasyan A, Salas AA, Nolen T, Chomba E, Mazariegos M, Tshefu Kitoto A, Saleem S, Naqvi F, Hambidge KM, Goco N, McClure EM, Wallander JL, Biasini FJ, Goldenberg RL, Bose CL, Koso-Thomas M, Krebs NF, Carlo WA. Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries. BMJ Open. 2023 May 23;13(5):e065076. doi: 10.1136/bmjopen-2022-065076.

Reference Type: DERIVED

PMID: 37221030 (View on PubMed)

Krebs NF, Mazariegos M, Chomba E, Sami N, Pasha O, Tshefu A, Carlo WA, Goldenberg RL, Bose CL, Wright LL, Koso-Thomas M, Goco N, Kindem M, McClure EM, Westcott J, Garces A, Lokangaka A, Manasyan A, Imenda E, Hartwell TD, Hambidge KM. Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings. Am J Clin Nutr. 2012 Oct;96(4):840-7. doi: 10.3945/ajcn.112.041962. Epub 2012 Sep 5.

Reference Type: DERIVED

PMID: 22952176 (View on PubMed)

Krebs NF, Hambidge KM, Mazariegos M, Westcott J, Goco N, Wright LL, Koso-Thomas M, Tshefu A, Bose C, Pasha O, Goldenberg R, Chomba E, Carlo W, Kindem M, Das A, Hartwell T, McClure E; Complementary Feeding Study Group. Complementary feeding: a Global Network cluster randomized controlled trial. BMC Pediatr. 2011 Jan 13;11:4. doi: 10.1186/1471-2431-11-4.

Reference Type: DERIVED

PMID: 21232139 (View on PubMed)

Other Identifiers

GN CF

Identifier Type: -

Identifier Source: org_study_id