Peer Groups to Improve Infant Feeding Practices and Child Growth in Post-emergency Settlements in Uganda

NCT05584969 | Completed DMC

• 1 other identifier: HS-19-2
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized trial was to examine whether a peer-to-peer integrated intervention using Care Groups combining nutrition education and social support will improve infant growth and complementary feeding practices among refugees in the West-Nile region in Uganda. The aims of the study were to 1) determine the relationship of the intervention using the Care Group model on complementary feeding of infants, and 2) investigate the effects of a peer-led integrated nutrition education intervention using the Care Group model on growth among infants of refugees in Uganda. Pregnant mothers (390) in their 3rd trimester were enrolled in a peer-led nutrition education intervention using the Care Group model. One treatment arm had moms only in the Care Groups while the other treatment arm had both moms and dads in the groups. Each study arm had a total of 10 Care Groups with 10-20 participants each. The control arm equally had 10 groups, however, did not receive the intervention. Each of the treatment arms participated in a biweekly integrated nutrition training hypothesized to effect behavioral change in infant feeding practices. The biweekly training started in March 2022 and ended in December 2022 with data collection at four-time points during the study (baseline, midline-I, II, and endline). Infant complementary feeding was evaluated using the World Health Organization \& UNICEF guidelines. Infant growth was assessed using length-for-age z-scores, weight-for-age z-scores and weight-for-length z-scores. The Medical Outcomes Study (MOS) Social Support Index was used as a proxy to measure maternal social support. Effects of Care Group intervention on infant complementary feeding and growth were tested by study arm compared to the control arm.

Conditions

Infant Malnutrition

Keywords

Infant complementary feeding; Refugees; Post-emergency settlements; Infant growth; Uganda; Maternal social support

Outcome Measures

Primary Outcomes (8)

• Introduction of solid and semi-solid or soft foods (ISSSF)

  Proportion of infants introduced to solid, semi-solid or soft foods at 6 months, continually breastfed and were between 6 - 8 months of age

  through study completion, an average of 1 year

• Infant minimum dietary diversity scores (MDD)

  Proportion of infants in the age category 6 - 23 months who consumed at least five food groups of the recommended eight in the past 24 hours. The food groups include - currently breastfed; roots and tubers; grains; flesh foods (meat, fish, poultry, and organ meats); legumes and nuts; dairy products; vitamin A-rich fruits and vegetables; eggs; other fruits and vegetables

  through study completion, an average of 1 year

• Infant minimum meal frequency (MMF)

  Proportion of infants in the age category 6 - 23 months who consumed solid, semi-solid or soft foods including snacks the recommended minimum number of times for both breastfed and non-breastfed infants. That is, a minimum of * 2 feedings for breastfed infants 6 - 8 months of age * 3 feedings for breastfed infants in the 9 - 23 months of age category * 4 feeding for non-breastfed infants in 6 - 23 months age category.

  through study completion, an average of 1 year

• Infant minimum acceptable diet (MAD)

  Proportions of infants who met composite indicator of optimal age specific frequency of meals and the adequate variety i.e. * Breastfed infants in the 6 - 23 months age range with adequate minimum dietary diversity and meal frequency in the past 24 hours * Non-breastfed infants within 6 - 23 months with adequate minimum dietary diversity and meal frequency in the past 24 hours in addition to at least two milk feeds

  through study completion, an average of 1 year

• Eggs and or flesh foods consumption (EFF)

  Proportion of infants between 6 - 23 months who consumed an egg or flesh foods in the previous day.

  through study completion, an average of 1 year

• infant stunting

  Length-for-age z-scores (LAZ)(The z-scores were calculated after subtracting the measured length of a child from the median value of the reference population and adjusted for sex and age). A cutoff of - 2 z-score indicates stunting.

  through study completion, an average of 1 year

• infant underweight

  Weight-for-age z-scores (WAZ)(The z-scores were calculated after subtracting the measured weight of a child from the median value of the reference population and adjusted for sex and age). A cutoff of - 2 z-score indicates underweight.

  through study completion, an average of 1 year

• infant wasting

  Weight-for-length z-scores (WAZ)(The z-scores were calculated after subtracting the measured length and weight of a child from the median value of the reference population and adjusted for sex and age). A cutoff of - 2 z-score indicates wasting.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Maternal social support

  through study completion, an average of 1 year

Study Arms (3)

Moms-only treatment arm

EXPERIMENTAL

In this treatment arm, 10 Care Groups comprised of only mothers (10 - 20 participants per group) engaged in the peer-led intervention that consisted of infant feeding guidelines \[16\], cooking demonstrations, and backyard farming demonstrations conducted over 10 months. The peer-led trainings lasted 60 - 90 minutes and were conducted every two weeks and supervised by a selected VHT.

Behavioral: Peer-led integrated nutrition education intervention delivered through Care Groups

Moms and Dads treatment arm

EXPERIMENTAL

This treatment arm received a similar peer-led intervention to the Moms-only treatment arm, however, this arm comprised both moms and dads (a couple)

Behavioral: Peer-led integrated nutrition education intervention delivered through Care Groups

Control arm

NO INTERVENTION

This was the comparison arm of the study. No intervention was provided to the participants of this arm. However, all study arm participants accessed the standard of care which was the routine health services delivered through the government health centers.

Interventions

Peer-led integrated nutrition education intervention delivered through Care Groups BEHAVIORAL

The intervention comprised a peer-led integrated nutrition education training using the Care Group model developed by the TOPS program \[13\]. In the treatment arms, topics trained in the peer support groups included 1) group dynamics and social support, 2) infant feeding 3) adequate basic hygiene, 4) child growth and development, and 5) fathers' involvement. The training modules were adopted and modified from the community health extension workers (CHEWs) handbook \[14\] and the UNICEF IYCF counseling cards for community workers \[15, 16\]. Over the study, the intervention participants also engaged in cooking demonstrations targeting infant complementary foods preparation and backyard kitchen gardening.

Moms and Dads treatment arm; Moms-only treatment arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women of reproductive age (15 - 49 years) in their third trimester were eligible to participate in the study.
• Husbands were eligible to participate with their wives in the Moms \& Dads treatment arm

You may not qualify if:

• Mothers whose antenatal records showed pregnancy complications were excluded from the study.
• Mothers who gave birth to premature infants, infants with congenital abnormalities, or whose infants died had the option of remaining in the study but were excluded from the final analyses.

Sponsors & Collaborators

• Oklahoma State University: lead
• Lutheran World Federation: collaborator
• Makerere University: collaborator
• Nestlé Foundation for the Study of Problems of Nutrition in the World: collaborator

Study Sites (1)

Adjumani refugee settlements

Adjumani, 00256, Uganda

Location

Related Publications (22)

• UNHCR. Figures at a Glance: UNHCR, Geneva, Switzerland; 2020 [Available from: https://www.unhcr.org/en-us/figures-at-a-glance.html. Accessed January, 2022.

  BACKGROUND

• Corbett M, Oman A. Acute Malnutrition in Protracted Refugee Situations: A Global Strategy. Geneva, Switzerland: UNHCR/WFP; 2006.

  BACKGROUND

• Buscher D. New approaches to urban refugee livelihoods. Refuge: Canada's Journal on Refugees. 2013;28(2).

  BACKGROUND

• Ministry of Health Uganda, Uganda Bureau of Statistics, Office of the Prime Minister Uganda, UNHCR. Food Security and Nutrition Assessment in Refugee Settlements and Kampala. Kampala: MOH and UNHCR Representation Office in Uganda; 2020.

  BACKGROUND

• Style S, Tondeur M, Wilkinson C, Oman A, Spiegel P, Kassim IA, Grijalva-Eternod C, Dolan C, Seal A. Operational guidance on the use of special nutritional products in refugee populations. Food Nutr Bull. 2013 Dec;34(4):420-8. doi: 10.1177/156482651303400407.

  PMID: 24605692 BACKGROUND

• Blanchet K, Ramesh A, Frison S, Warren E, Hossain M, Smith J, Knight A, Post N, Lewis C, Woodward A, Dahab M, Ruby A, Sistenich V, Pantuliano S, Roberts B. Evidence on public health interventions in humanitarian crises. Lancet. 2017 Nov 18;390(10109):2287-2296. doi: 10.1016/S0140-6736(16)30768-1. Epub 2017 Jun 8.

  PMID: 28602563 BACKGROUND

• Marmot M, Friel S, Bell R, Houweling TA, Taylor S; Commission on Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health. Lancet. 2008 Nov 8;372(9650):1661-9. doi: 10.1016/S0140-6736(08)61690-6.

  PMID: 18994664 BACKGROUND

• Prudhon C, Benelli P, Maclaine A, Harrigan P, Frize J. Informing infant and young child feeding programming in humanitarian emergencies: An evidence map of reviews including low and middle income countries. Matern Child Nutr. 2018 Jan;14(1):e12457. doi: 10.1111/mcn.12457. Epub 2017 Jul 3.

  PMID: 28670790 BACKGROUND

• WFP, UNHCR. Food Security and Nutrition Assessment in Refugee Settlements, Uganda 2017. Final Report. UNHCR SENS-Version 2. 2017.

  BACKGROUND

• UNHCR. Uganda Comprehensive Refugee Response Portal 2020 [Available from: https://ugandarefugees.org/en/country/uga. Accessed February 2019

  BACKGROUND

• Arikpo D, Edet ES, Chibuzor MT, Odey F, Caldwell DM. Educational interventions for improving primary caregiver complementary feeding practices for children aged 24 months and under. Cochrane Database Syst Rev. 2018 May 18;5(5):CD011768. doi: 10.1002/14651858.CD011768.pub2.

  PMID: 29775501 BACKGROUND

• Waswa LM, Jordan I, Herrmann J, Krawinkel MB, Keding GB. Community-based educational intervention improved the diversity of complementary diets in western Kenya: results from a randomized controlled trial. Public Health Nutr. 2015 Dec;18(18):3406-19. doi: 10.1017/S1368980015000920. Epub 2015 Apr 10.

  PMID: 25857703 BACKGROUND

• Food Security & Nutrition Network Social & Behavioral Change Task Force. Care Groups: A Training Manual for Program Design and Implementation. Washington D.C,: Technical and Operational Performance Support Program; 2014.

  BACKGROUND

• Government of Uganda. Village Health Team: Participant Manual for Village Health Team Members. In: Ministry of Health, editor. Kampala, Uganda: Ministry of Health, Uganda; 2002.

  BACKGROUND

• UNICEF. The Community IYCF Counselling Cards for Community Workers. In: United Nations Children's Fund, editor. Online. New York: UNICEF; 2020.

  BACKGROUND

• UNICEF. The Community Infant and Young Child Feeding Counselling Package New York: UNICEF; 2022 [Available from: https://www.unicef.org/documents/community-iycf-package. Accessed March 2019.

  BACKGROUND

• Turinawe EB, Rwemisisi JT, Musinguzi LK, de Groot M, Muhangi D, de Vries DH, Mafigiri DK, Pool R. Selection and performance of village health teams (VHTs) in Uganda: lessons from the natural helper model of health promotion. Hum Resour Health. 2015 Sep 7;13:73. doi: 10.1186/s12960-015-0074-7.

  PMID: 26346431 BACKGROUND

• Macro International. Demographic and Health Surveys (DHS). https://dhsprogram.com/ 2018: Accessed November 2018.

  BACKGROUND

• UNHCR. Standardised Expanded Nutrition Survey Guidelines for Refugee Populations (Version 3). 2019.

  BACKGROUND

• Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.

  PMID: 2035047 BACKGROUND

• Komakech JJ, Emerson SR, Cole KL, Walters CN, Rakotomanana H, Kabahenda MK, Hildebrand DA, Stoecker BJ. Care groups in an integrated nutrition education intervention improved infant growth among South Sudanese refugees in Uganda's West Nile post-emergency settlements: A cluster randomized trial. PLoS One. 2024 Mar 15;19(3):e0300334. doi: 10.1371/journal.pone.0300334. eCollection 2024.

  PMID: 38489346 DERIVED

• Komakech JJ, Emerson SR, Cole KL, Walters CN, Rakotomanana H, Kabahenda MK, Hildebrand DA, Stoecker BJ. A Peer-Led Integrated Nutrition Education Intervention through Care Groups Improved Complementary Feeding of Infants in Postemergency Settlements in the West-Nile Region in Uganda: A Cluster Randomized Trial. Curr Dev Nutr. 2023 Feb 3;7(3):100042. doi: 10.1016/j.cdnut.2023.100042. eCollection 2023 Mar.

  PMID: 37181933 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Joel J Komakech, Ph.D.

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The settlements that were assigned to the different study arms were at least 6 kilometers apart to reduce the possibility of spillover effects of the intervention. The participants in each study arm were blinded from 1) which other settlements were involved in the activities they were engaging in and 2) what activities were and who was involved in those activities within the other study arms. Data collectors/enumerators were blinded from the study arm assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention in Moms-only arm was run concurrently with a similar intervention in the Moms and Dads treatment arm. At the same time, the Control arm did not receive any intervention. Data were collected from all study arms at the same time during the study in order to compare the effect of the intervention in the treatment arms against the control.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: January 9, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available from December 2021 to December 2031 (10 years)
• Access Criteria: The study data will be shared on request from the principal investigator.

Locations

UG (1)