Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2018
Date assigned
04/06/2018
Last edited
04/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Adolescence is a critical period in the lives of young people, and potentially a time to reap lasting benefits from interventions that improve general, nutritional, sexual, reproductive, and maternal and child health. Undernutrition in adolescent girls can have a direct impact on their immune function and susceptibility to infectious diseases, as well as increase mortality risk during childbirth. Micronutrient deficiencies, including iron, Vitamin A, and zinc deficiency, frequently result in lethargy and depression, and are associated with decreased cognitive function and productivity. Anemia is a critical health concern among pregnant adolescents who, if anemic, have an increased risk of death. Data from national surveys in Zambia indicate a high prevalence of deficiencies in both macro and micronutrients. The aim of this study is to assess the impact of an adolescent girls’ empowerment program that includes a nutritional educational component on nutritional knowledge, behaviors and health outcomes. A broader objective is to provide evidence for the Zambian national government ministries to set policy priorities and develop strategic plans for scaling up cost-effective programs that address nutritional deficiencies in adolescent girls. The findings will also inform stakeholders and civil society working on nutrition and nutrition-sensitive interventions. A final aim is to inform donors about cost-effective approaches that increase the impact of nutrition interventions. Additionally, the study contributes to the knowledge base of nutritional research and effective methods for addressing anemia and other nutritional deficiencies in adolescent girls and their children.

Who can participate?
Vulnerable, never married adolescent girls aged 10–19, selected among all girls participating in a girls’ empowerment program conducted over 2 years in urban and rural areas in four provinces of Zambia. In urban areas girls are selected from high-density housing compounds in the cities of Lusaka, Kabwe, Ndola and Kitwe. In rural areas, girls are selected from multiple adjacent villages or chiefdoms in Central, Copperbelt and Northwestern provinces. The empowerment program identified and targeted the most vulnerable girls living in selected program areas.

What does the study involve?
The program areas are randomly allocated to receive the empowerment program or to not receive the program. Girls participating in the empowerment program’s weekly girls’ groups are additionally randomly allocated to receive, or not, the educational curriculum guided sessions on nutrition. All girls selected to participate in the curriculum learn about general topics about food, micro and macro nutrients, and anemia; older adolescents 15–19, receive additional information on nutrition during pregnancy and proper infant and child feeding behaviors. All girls in the empowerment program girls’ groups, regardless of whether they additionally receive the nutritional education component, participate in mentor-led sessions on the topics of sexual and reproductive health, life skills and financial education.

What are the possible benefits and risks of participating?
The benefits of participation are information regarding proper nutrition and anemia for themselves and their children, sexual reproductive health, life skills and financial education. Additionally, girls who participate in the research are tested for anemia, counselled on the results and referred to health services if found to be severely anemic. There are very minimal risks to the participant. The risks include any sensitivities to answering questions about themselves and, for those tested for anemia, from infection to the puncture of the finger prick.

Where is the study run from?
The study is community-based with interviews conducted at households within selected urban and rural areas of four provinces of Zambia

When is the study starting and how long is it expected to run for?
November 2012 to July 2018

Who is funding the study?
Department for International Development (UK)

Who is the main contact?
Dr Karen Austrian
kaustrian@popcouncil.org

Trial website

http://www.popcouncil.org/research/adolescent-girls-empowerment-program

Contact information

Type

Public

Primary contact

Dr Karen Austrian

ORCID ID

Contact details

The Population Council
Avenue 5
3rd Floor
Rose Avenue
PO Box 17643-00500
Nairobi
PO Box 17643 - 00500
Kenya
+254 20 271 3480
kaustrian@popcouncil.org

Type

Scientific

Additional contact

Dr Paul C. Hewett

ORCID ID

http://orcid.org/0000-0003-0394-3154

Contact details

4301 Connecticut Avenue
Washington D.C.
20008
United States of America
+12022379419
phewett@popcouncil.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Population Council Protocol 581; University of Zambia, Biomedical Research Ethics Committee protocol 008-11-12

Study information

Scientific title

Evaluation of the impact a randomized educational nutritional intervention on nutritional knowledge, dietary intake and anthropometric outcomes for girls 10-19 years of age participating in a The Adolescent Girls' Empowerment Program in Zambia

Acronym

Study hypothesis

1. The intervention will improve nutritional knowledge among exposed participants compared to unexposed participants
2. The intervention will improve dietary intake among exposed participants and their children compared to unexposed participants and their children
3. The intervention will improve anthropometric outcomes among exposed participants and their children compared to unexposed participants and their children

Ethics approval

1. Population Council, Institutional Review Board, 24/10/2013, ref: 581
2. University of Zambia, Biomedical Research Ethics Committee, ref: 008-11-12

Study design

Two-arm randomized cluster evaluation

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Insufficient dietary intake, stunting, thinness, underweight, overweight, obesity, anemia

Intervention

Participants in this study included vulnerable, never married adolescent girls aged 10–19. The girls were selected among all girls participating in a girls’ empowerment program conducted over two-years and implemented urban and rural areas in four provinces of Zambia. In urban areas girls were selected from high-density housing compounds in the cities of Lusaka, Kabwe, Ndola and Kitwe. In rural areas, girls were selected from multiple adjacent villages or chiefdoms in Central, Copperbelt and Northwestern provinces. The empowerment program identified and targeted the most vulnerable girls living in selected program areas. A random selection process determined whether girls in the pre-selected programs areas would be invited to participate in the empowerment program or would be assigned to non-program areas (control).

The Adolescent Girls Empowerment Program targeted adolescent girls drawn from lower-income backgrounds and invited them to participate in mentor-led weekly girls group meetings over the course of two years. Three curricula guided the meetings, including health and life skills, financial education and nutrition for adolescent girls. Half of the weekly girls' groups (mentors) were randomly assigned to an arm that included the nutritional curriculum, while half of the girls' groups (mentors) were randomly assigned to an arm that did not implement the nutritional curriculum.

All girls selected to participate in the nutritional curriculum learned about general topics about food, micro and macro nutrients, and anemia; older adolescents 15–19, received additional information on nutrition during pregnancy and proper infant and child feeding behaviors.

All girls in the empowerment program girls’ groups, regardless of whether they additionally received the nutritional education component, participated in mentor-led sessions on the topics of sexual and reproductive health, life skills and financial education.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Survey data was collected annually, with Round 1 starting in 2013:
1. Nutritional knowledge: health/unhealthy foods; causes and signs and symptoms of anemia; proper infant and child feeding practices measured through survey interviews annually (Round 3-Round 5)
2. Nutritional behavior: dietary diversity, eating of nutrient rich foods, infant and child feeding practices measured through survey interviews annually (Round 1-Round 5)

Secondary outcome measures

1. Nutritional outcomes (stunting, thinness, underweight, overweight, obesity) using anthropometric measurements (Round 1-Round 5)
2. Anemia measured using point-of-care anemia testing (Round 3-Round 5)

Overall trial start date

14/11/2012

Overall trial end date

30/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Residing in areas covered by the intervention program
2, Aged 10-19 at baseline
3. Assigned to a program girls group (mentor)
4. Sampled for the AGEP program evaluation

Participant type

Other

Age group

Mixed

Gender

Female

Target number of participants

2,660

Participant exclusion criteria

1. Currently or formerly married at baseline

Recruitment start date

07/01/2013

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Zambia

Trial participating centre

Lusaka Province, Zambia
-
Zambia

Sponsor information

Organisation

Population Council

Sponsor details

One Dag Hammarskjold Plaza
New York
10017
United States of America
12123390500
pubinfo@popcouncil.org

Sponsor type

Research organisation

Website

www.popcouncil.org

Funders

Funder type

Government

Funder name

Department for International Development, UK Government

Alternative name(s)

Department for International Development, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Manuscript submission to a peer-reviewed journal is expected in quarter 3 of 2018.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Paul C. Hewett (phewett@popcouncil.org); Karen Austrian (kaustrian@popcouncil.org). Type of data: individual level survey data, biomarker data, anthropometric data. Availability of data: currently available, no end date of availability. Criteria: user must complete a data use agreement form to access the data and obtain approval for use; there are generally no restrictions on the data use for program or research purposes, an exception is when there is a conflicts with other researchers and/or investigators who planned to publish on certain topics; these are evaluated on a case-by-case basis. Mechanism: the data and instruments are downloadable. Written informed consent (adults) or parental/guardian consent and minor assent (aged < 18 years) was obtained for all aspects of study participation and data collection. The data publicly available has been de-identified to protect the confidentiality of study participants. The data can be used only for non-commercial purposes.

Intention to publish date

01/10/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes