Health Education, CommunityNCT02800564
Change in Child-feeding Knowledge, Attitudes, and Practices With Nutrition Education Mass Media in Ghana
A study testing Active mass media approach and Passive mass media approach in people with Health Education, Community and Diet, Food, and Nutrition, run by McGill University at 4 sites in 2 countries.
Trial summary
Optimal infant and young child feeding practices are largely inadequate in rural and poor households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and growth monitoring and promotion (GMP) activities among infants and young children (IYC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Education, Community, Diet, Food, and Nutrition, Malnutrition
- What is being tested?
- Active mass media approach and Passive mass media approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Apr 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- lives in cluster randomly assigned to either active or passive arm
- has child < 5 y of age
- is the primary caregiver of the child
Who cannot join
- has physical condition/illness that prevents from taking care of child
- has physical condition/illness that prevents from responding to surveys
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada2 sites
McGill University
Montreal, Quebec, H3A 2T5
World Vision
Toronto, Ontario
About this study
Official title: Assessing Change in Knowledge, Attitudes, and Practices of Mothers With Infants and Young Children Receiving a District-wide Interactive Nutrition Education Mass Media Programme in the Upper Manya Krobo District
Optimal infant and young child feeding practices are largely inadequate in rural and poor households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and growth monitoring and promotion (GMP) activities among infants and young children (IYC). An essential component of GMP activities is to counsel mothers to practice optimal IYC feeding and health practices, but most of the time this is completely missing or not specific enough to be effective.
This study will test the effect of a mass media nutrition education program on caregiver infant and young child feeding knowledge, attitudes and practices using a community-based cluster randomized design. Formative research will first be undertaken to determine the beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their infants and young children with members of the community (caregivers with children under-five, men and elderly women).The information gathered will then be used to design specific messages that directly address the IYC feeding challenges of the community. Clusters will be randomized into active (radio messages with in-person engagement and follow-up) and passive (only radio messages) arms of the intervention. Farm Radio International (implementers of the mass media programming) will ensure the regular broadcast of twice weekly messages for a period of about 12-18 months.
Read the detailed description
This study will be a community-based cluster randomized controlled trial. All communities in the Upper Manya Krobo District (UMKD) that are accessible 12 months of the year (with the exception of 19 communities that are participating in an agriculture-education intervention) will be considered eligible. These communities (n =168) will be stratified based on sub-district and the median community population size for the sub-district. Four communities will be randomly selected from each sub-district: two large and two small communities. These 24 communities will then be randomly assigned to active or passive radio engagement.
Each community will be considered a cluster. To achieve a total sample of 1258 caregivers, 52 women per cluster will be enrolled. If researchers are unable to enroll the sample size in one community, the cluster will be expanded to include the closest village and enrolment will continue until the sample size is achieved.
Enrolment strategy. A census of all communities was completed in 2013 and will be used to decide on the selection strategy. Field workers a priori will randomly select the 52 households in each cluster (only one mother per household, randomly chosen if there is > 1). If the selected household does not have a child < 5 y of age, the closest house will be approached. This will continue until enrolment is completed.
Data Collection Procedures
Phase 1: Baseline survey
A baseline survey will be carried out to document the prevailing IYC feeding knowledge, attitudes and practices of caregivers using a semi-structured questionnaire. Questions will cover:
- socio-demographic information
- radio ownership and listening practices
- exposure to other sources of nutrition education in the district
- IYC feeding knowledge and practices
- knowledge and awareness about anaemia
- knowledge and awareness about undernutrition
- knowledge, attitudes and practices about water, sanitation, and hygiene
Phase 2: Formative research
The formative research will begin in only the active engagement communities.
The total sample for the formative research will be no more than 144 women with children under 5 years of age 144 men with children under 5 years of age, and 144 elderly women who take care of children under 5 years of age. Participation will be solicited at a community-wide meeting to explain the project. Interested individuals will be included until the sample size is reached. Written informed consent will be obtained as noted below.
Participation in the formative research will include:
(i) Farm Radio International (implementers of the mass media programming) will carry out the focus groups to determine the beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their infants and young children. In addition, information on radio-listening habits, time preference for programmes, and formats that are of interest to the communities will be collected. Information gathered will be used to design radio nutrition and health messages and jingles that directly address the IYC feeding challenges in the area. Three focus group discussions will be undertaken in each of the 12 active radio engagement communities. The focus groups will include 8-12 individuals each, for the following groups: i) women with children under 5 years of age ii) men with children under 5 years of age iii) elderly women who take care of children under 5 years of age (grandmothers, great aunts)
(ii) These same participants from the focus groups will be followed up and will take part in monthly and quarterly assessments of the radio programming using semi-structured questionnaires. The aims of these assessments are:
- obtain feedback from community members to improve content the radio messages, ii) determine whether the messages are being received as intended, and iii) assess intermediary adoption of messages
Phase 3: Intervention
The interactive radio education intervention will involve weekly radio programming with local radio stations on key nutrition and health topics for up to 18 months. The topics will be consistent with the Ministry of Health's community nutrition and health education messages. The programme will be repeated once every week. The intensity of the intervention for an individual will differ based on the assignment of the participant's community:
See description of the active and passive arms.
Phase 4: Post-intervention survey
An endline survey will be carried out within a maximum of 3 months after the end of the mass media intervention, to determine the effect of the intervention on IYC feeding and sanitation knowledge, attitudes and practices of caregivers. The questions will cover:
- recollection of key messages (free recall-no probes)
- self-reported level of engagement with radio programming
- exposure to other sources of nutrition education in the district
- IYC feeding knowledge and practices
- knowledge and awareness about anaemia
- knowledge and awareness about undernutrition
- knowledge, attitudes and practices about water, sanitation and hygiene The endline survey will be completed with all 1258 women who participated in the baseline survey.
Data Analysis Focus Group Data All recordings of the focus group discussions will transcribed from the local language (Krobo and Twi) to English and analyzed using N-Vivo version10. The thematic content analysis approach will be used to analyze the data. Common themes emerging from the discussions will be grouped and the results summarized based on these themes. Selected quotes of participants will also be presented.
Change from baseline in self-reported knowledge, attitudes and practices. All analysis will be by intention-to-treat basis. Analyses will be performed on individual level summaries using a difference-in-difference (DiD) approach. For each target knowledge, attitude and behavior, the reported prevalence will be estimated at baseline and endline, and the difference between surveys calculated. ANOVA tests will be used to detect differences in caregiver infant and young child feeding knowledge, attitudes and practices between intervention group and control group while adjusting for important baseline characteristics and the effect of cluster.
- Conditions
- Health Education, Community, Diet, Food, and Nutrition, Malnutrition, Infant Nutritional Sciences
- Being tested
- Active mass media approach, Passive mass media approach
- Medical subject headings
- Health Education, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active mass media approachBehavioural
Communities will be exposed to twice weekly radio programming for up to 18 months. Interactive voice response systems (IVRS) will be promoted where listeners can chose to receive pre-recorded audio/voice messages or text messages on mobile phones. Messages will be consistent with the weekly radio program. The topic of the radio program will be discussed in monthly open community meetings. Each individual may choose to participate or not to listen to the radio program, receive the IVRS system, and attend monthly meetings.
Passive mass media approachBehavioural
These communities will be exposed to twice weekly radio programming for up to 18 months only.
| Study group | Role | What they receive |
|---|---|---|
| Active mass media approach | Experimental | Communities will be exposed to twice weekly radio programming for up to 18 months plus interactive voice response systems (IVRS) and monthly open community meetings. Receives: Behavioral: Active mass media approach |
| Passive mass media approach | Experimental | Communities will be exposed to twice weekly radio programming for up to 18 months Receives: Behavioral: Passive mass media approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant feeding behaviour assessed by questionnaire
Change in child feeding behaviours that are promoted on radio
Measured: 12-18 months
Secondary outcomes (2)
Change in infant feeding knowledge of mother assessed by questionnaire
Change in knowledge about child feeding that is promoted on radio
Measured: 12-18 months
Change in infant feeding attitudes of mother assessed by questionnaire
Change in attitudes about child feeding that are discussed on radio
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Apr 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Education, CommunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Affairs Canada, World Vision
- Responsible party
- Principal investigator, Grace S. Marquis, McGill University
- Investigators
- Grace S Marquis, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800564
- Sponsor's protocol ID
- S065653b
- Status last verified
- Mar 2018
- First submitted
- 8 Jun 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Change in Knowledge, Attitudes, and Practices of Mothers With Infants and Young Children Receiving a District-wide Interactive Nutrition Education Mass Media Programme in the Upper Manya Krobo District
- ClinicalTrials.gov ID
- NCT02800564
- Acronym / sponsor ID
- S065653b
- Conditions
- Health Education, Community, Diet, Food, and Nutrition, Malnutrition, Infant Nutritional Sciences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Global Affairs Canada, World Vision
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimal infant and young child feeding practices are largely inadequate in rural and poor households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and growth monitoring and promotion (GMP) activities among infants and young children (IYC). An essential component of GMP activities is to counsel mothers to practice optimal IYC feeding and health practices, but most of the time this is completely missing or not specific enough to be effective.
This study will test the effect of a mass media nutrition education program on caregiver infant and young child feeding knowledge, attitudes and practices using a community-based cluster randomized design. Formative research will first be undertaken to determine the beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their infants and young children with members of the community (caregivers with children under-five, men and elderly women).The information gathered will then be used to design specific messages that directly address the IYC feeding challenges of the community. Clusters will be randomized into active (radio messages with in-person engagement and follow-up) and passive (only radio messages) arms of the intervention. Farm Radio International (implementers of the mass media programming) will ensure the regular broadcast of twice weekly messages for a period of about 12-18 months.
Detailed description
This study will be a community-based cluster randomized controlled trial. All communities in the Upper Manya Krobo District (UMKD) that are accessible 12 months of the year (with the exception of 19 communities that are participating in an agriculture-education intervention) will be considered eligible. These communities (n =168) will be stratified based on sub-district and the median community population size for the sub-district. Four communities will be randomly selected from each sub-district: two large and two small communities. These 24 communities will then be randomly assigned to active or passive radio engagement.
Each community will be considered a cluster. To achieve a total sample of 1258 caregivers, 52 women per cluster will be enrolled. If researchers are unable to enroll the sample size in one community, the cluster will be expanded to include the closest village and enrolment will continue until the sample size is achieved.
Enrolment strategy. A census of all communities was completed in 2013 and will be used to decide on the selection strategy. Field workers a priori will randomly select the 52 households in each cluster (only one mother per household, randomly chosen if there is > 1). If the selected household does not have a child < 5 y of age, the closest house will be approached. This will continue until enrolment is completed.
Data Collection Procedures
Phase 1: Baseline survey
A baseline survey will be carried out to document the prevailing IYC feeding knowledge, attitudes and practices of caregivers using a semi-structured questionnaire. Questions will cover:
- socio-demographic information
- radio ownership and listening practices
- exposure to other sources of nutrition education in the district
- IYC feeding knowledge and practices
- knowledge and awareness about anaemia
- knowledge and awareness about undernutrition
- knowledge, attitudes and practices about water, sanitation, and hygiene
Phase 2: Formative research
The formative research will begin in only the active engagement communities.
The total sample for the formative research will be no more than 144 women with children under 5 years of age 144 men with children under 5 years of age, and 144 elderly women who take care of children under 5 years of age. Participation will be solicited at a community-wide meeting to explain the project. Interested individuals will be included until the sample size is reached. Written informed consent will be obtained as noted below.
Participation in the formative research will include:
(i) Farm Radio International (implementers of the mass media programming) will carry out the focus groups to determine the beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their infants and young children. In addition, information on radio-listening habits, time preference for programmes, and formats that are of interest to the communities will be collected. Information gathered will be used to design radio nutrition and health messages and jingles that directly address the IYC feeding challenges in the area. Three focus group discussions will be undertaken in each of the 12 active radio engagement communities. The focus groups will include 8-12 individuals each, for the following groups: i) women with children under 5 years of age ii) men with children under 5 years of age iii) elderly women who take care of children under 5 years of age (grandmothers, great aunts)
(ii) These same participants from the focus groups will be followed up and will take part in monthly and quarterly assessments of the radio programming using semi-structured questionnaires. The aims of these assessments are:
- obtain feedback from community members to improve content the radio messages, ii) determine whether the messages are being received as intended, and iii) assess intermediary adoption of messages
Phase 3: Intervention
The interactive radio education intervention will involve weekly radio programming with local radio stations on key nutrition and health topics for up to 18 months. The topics will be consistent with the Ministry of Health's community nutrition and health education messages. The programme will be repeated once every week. The intensity of the intervention for an individual will differ based on the assignment of the participant's community:
See description of the active and passive arms.
Phase 4: Post-intervention survey
An endline survey will be carried out within a maximum of 3 months after the end of the mass media intervention, to determine the effect of the intervention on IYC feeding and sanitation knowledge, attitudes and practices of caregivers. The questions will cover:
- recollection of key messages (free recall-no probes)
- self-reported level of engagement with radio programming
- exposure to other sources of nutrition education in the district
- IYC feeding knowledge and practices
- knowledge and awareness about anaemia
- knowledge and awareness about undernutrition
- knowledge, attitudes and practices about water, sanitation and hygiene The endline survey will be completed with all 1258 women who participated in the baseline survey.
Data Analysis Focus Group Data All recordings of the focus group discussions will transcribed from the local language (Krobo and Twi) to English and analyzed using N-Vivo version10. The thematic content analysis approach will be used to analyze the data. Common themes emerging from the discussions will be grouped and the results summarized based on these themes. Selected quotes of participants will also be presented.
Change from baseline in self-reported knowledge, attitudes and practices. All analysis will be by intention-to-treat basis. Analyses will be performed on individual level summaries using a difference-in-difference (DiD) approach. For each target knowledge, attitude and behavior, the reported prevalence will be estimated at baseline and endline, and the difference between surveys calculated. ANOVA tests will be used to detect differences in caregiver infant and young child feeding knowledge, attitudes and practices between intervention group and control group while adjusting for important baseline characteristics and the effect of cluster.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active mass media approach | Experimental | Behavioral: Active mass media approachCommunities will be exposed to twice weekly radio programming for up to 18 months plus interactive voice response systems (IVRS) and monthly open community meetings. |
| Passive mass media approach | Experimental | Behavioral: Passive mass media approachCommunities will be exposed to twice weekly radio programming for up to 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- lives in cluster randomly assigned to either active or passive arm
- has child < 5 y of age
- is the primary caregiver of the child
Key exclusion criteria (2 listed)
- has physical condition/illness that prevents from taking care of child
- has physical condition/illness that prevents from responding to surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active mass media approachCommunities will be exposed to twice weekly radio programming for up to 18 months. Interactive voice response systems (IVRS) will be promoted where listeners can chose to receive pre-recorded audio/voice messages or text messages on mobile phones. Messages will be consistent with the weekly radio program. The topic of the radio program will be discussed in monthly open community meetings. Each individual may choose to participate or not to listen to the radio program, receive the IVRS system, and attend monthly meetings. | Behavioural | Active mass media approach |
| Passive mass media approachThese communities will be exposed to twice weekly radio programming for up to 18 months only. | Behavioural | Passive mass media approach |
Primary outcome
Change in infant feeding behaviour assessed by questionnaire
Time frame: 12-18 months
Change in child feeding behaviours that are promoted on radio
2 secondary outcomes
Change in infant feeding knowledge of mother assessed by questionnaire
Time frame: 12-18 months
Change in infant feeding attitudes of mother assessed by questionnaire
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace S Marquis, PhD principal investigator
McGill University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active mass media approach and Passive mass media approach in people with Health Education, Community and Diet, Food, and Nutrition, run by McGill University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infant feeding behaviour assessed by questionnaire (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.