Weight GainNCT05592834
Caregiver Led Strategies to Malnutrition and Care-giving Among Children With Cerebral Palsy
A study testing positive deviance hearth strategy and Parent facilitator trainings in people with Weight Gain, run by Makerere University at 1 site in Uganda.
Trial summary
The goal of this factorial trial is to test and compare the effectiveness of two caregiver led strategies, i.e., the positive deviance nutrition(PD) strategy and the parent facilitator training (PFT) strategies, to malnutrition and care-giving among children and youth with cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 24 years
- Conditions the study is for
- Weight Gain
- What is being tested?
- positive deviance hearth strategy and Parent facilitator trainings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUganda
- Study dates
- 1 Aug 2022to 17 Dec 2022
- 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 2 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Malnourished children and youth (<-2sd in any of height for age, weight for age and body mass index for age z-scores) with CP
- Caregivers of malnourished children and youth with CP
Who cannot join
- Caregivers registered in other nutrition interventions
- severely malnourished children that require life-saving nutrition management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Positive Deviance and Parent Facilitator Training Strategies to Malnutrition and Caregiving Among Children and Youth With CP in the Iganga, Mayuge and Bugweri Rural Districts of Eastern Uganda"
The goal of this factorial trial is to test and compare the effectiveness of two caregiver led strategies, i.e., the positive deviance nutrition(PD) strategy and the parent facilitator training (PFT) strategies, to malnutrition and care-giving among children and youth with cerebral palsy. Participants will be assigned to receive either of the four conditions, including,
- PFT only,
- PD only,
- Both the PFT and PD,
- None of the PD or PFT (controls) Researchers will compare either groups to see if there is an improvement in the nutritional status by weight gain and care giving knowledge and practices
Read the detailed description
High malnutrition and related mortality risk is common among children with cerebral palsy (CP) in most low- and middle-income countries. This is partly due to limited access to mainstream health care services worsened by the scarcity of health professionals with an extra skill in special needs care, including the ability to manage feeding difficulties common in the CP population. Families of children with CP have thus been left alone to care for their child without a clear direction on how to provide the best care including effective feeding and nutrition practices. This amplifies the relevance of caregivers in the improvement of CP child survival, and justifies the need for affordable and culturally acceptable strategies.
Training of caregivers of children with CP as lay professionals has become a cost-effective strategy to address the physical rehabilitation workforce gap in some African countries. However, the effectiveness of these strategies is not properly evaluated with regards to managing malnutrition in CP. Furthermore, caregiver-initiated strategies like the positive deviance nutrition strategy although proven effective in the management of malnutrition among typically developed children, its effectiveness in the CP child population is not clear. This study seeks to evaluate the effectiveness of caregiver led strategies i.e., the positive deviance and parent facilitator training (physical rehabilitation) strategies, to malnutrition and care-giving among children and youth with CP in eastern Uganda.
Study Objective: To determine the difference in the effectiveness of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and youth with cerebral palsy in the Iganga Mayuge and Bugweri districts.
Study setting: The study will be conducted within the districts of Iganga, Mayuge and Bugweri in eastern Uganda.
Study design: This will be a 2x2 factorial quasi-randomised controlled trial assessing the effects of the Positive deviance (PD) (Yes/No) and Parent facilitator training (PFT) (Yes/No) strategies within four experimental conditions: i) Both PD and PFT, ii) Only PD, iii)Only PFT, iv) Neither PD and nor PFT(controls).
Study population: The study population will include caregivers of malnourished children and youth aged 2-24 years old with a confirmed diagnosis of CP.
- Conditions
- Weight Gain
- Being tested
- positive deviance hearth strategy, Parent facilitator trainings, Control
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive deviance hearth strategyBehavioural
The PD-program is run for 3-months with 2 weeks (12 days) of nutrition education and rehabilitation sessions (NERS) conducted in each month. Each day session includes an half hour education session and a one and half hour peer led cooking session. Caretakers learn how to rehabilitate their malnourished children under the supervision and the support of caregivers who have well-nourished children (positive deviants). Children are nutritionally assessed by trained nutrition assistants or clinician on the 1st day of the NERS sessions and after three months.
During the rehabilitation sessions, caregivers learn how to prepare nutrient-rich meals for their children from locally available food identified during the positive deviance-inquiry, and actively practice good feeding and hygiene practices. Caregivers together prepare food menus based on the PD-inquiry good foods or what they can conveniently access but of equal nutritional value.
Parent facilitator trainingsBehavioural
Primary caregivers of children with CP residing in the study setting are trained as parent facilitators by expert physical rehabilitation therapist . Trained parent facilitators then hold fellow caregiver workshops each lasting approximately two hours long and includes between 6-10 caregivers. To ensure quality and consistency of the workshops, the Parent Facilitators follow a detailed manual adapted from the Carer-2-Carer Programme translated into Lusoga, the local language. No expert therapists is involved in the parent facilitator training workshops. Parent facilitator training workshops involve 7 sessions that expose caregivers to understanding CP and how to improve body functioning: session1: what is CP? session2: CP as a way of life, Session 3: Getting my child's body ready to move, Session 4: Eating and drinking a healthy diet, Session 5: communication, Session 6: Play, and Session 7: Central visual impairment.
ControlOther
This group will receive neither the PD nor the PFT interventions but care as usual
| Study group | Role | What they receive |
|---|---|---|
| Positive deviance (PD) | Experimental | This group will receive only the positive deviance intervention and not the PFT Receives: Behavioral: positive deviance hearth strategy |
| Parent facilitator training (PFT) | Experimental | This group will receive only the parent facilitator training intervention and not the PD Receives: Behavioral: Parent facilitator trainings |
| Parent facilitator and positive deviance(PFT/PD) | Experimental | This group will receive both the PD and PFT interventions Receives: Behavioral: positive deviance hearth strategy; Behavioral: Parent facilitator trainings |
| Control | Active comparator | This group will receive neither the PD nor the PFT interventions but care as usual. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Mean weight gain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Aug 2022
- Primary completion15 Nov 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This will be a 2x2 factorial quasi-randomised controlled trial assessing the effects of the Positive deviance (PD) (Yes/No) and Parent facilitator training (PFT) (Yes/No) strategies within four experimental conditions: i) Both PD and PFT, ii) Only PD, iii)Only PFT, iv) Neither PD and nor PFT(controls).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592834
- Sponsor's protocol ID
- HDREC 186
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Positive Deviance and Parent Facilitator Training Strategies to Malnutrition and Caregiving Among Children and Youth With CP in the Iganga, Mayuge and Bugweri Rural Districts of Eastern Uganda"
- ClinicalTrials.gov ID
- NCT05592834
- Acronym / sponsor ID
- HDREC 186
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 25 Oct 2022 (actual)
- 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.
The goal of this factorial trial is to test and compare the effectiveness of two caregiver led strategies, i.e., the positive deviance nutrition(PD) strategy and the parent facilitator training (PFT) strategies, to malnutrition and care-giving among children and youth with cerebral palsy. Participants will be assigned to receive either of the four conditions, including,
- PFT only,
- PD only,
- Both the PFT and PD,
- None of the PD or PFT (controls) Researchers will compare either groups to see if there is an improvement in the nutritional status by weight gain and care giving knowledge and practices
Detailed description
High malnutrition and related mortality risk is common among children with cerebral palsy (CP) in most low- and middle-income countries. This is partly due to limited access to mainstream health care services worsened by the scarcity of health professionals with an extra skill in special needs care, including the ability to manage feeding difficulties common in the CP population. Families of children with CP have thus been left alone to care for their child without a clear direction on how to provide the best care including effective feeding and nutrition practices. This amplifies the relevance of caregivers in the improvement of CP child survival, and justifies the need for affordable and culturally acceptable strategies.
Training of caregivers of children with CP as lay professionals has become a cost-effective strategy to address the physical rehabilitation workforce gap in some African countries. However, the effectiveness of these strategies is not properly evaluated with regards to managing malnutrition in CP. Furthermore, caregiver-initiated strategies like the positive deviance nutrition strategy although proven effective in the management of malnutrition among typically developed children, its effectiveness in the CP child population is not clear. This study seeks to evaluate the effectiveness of caregiver led strategies i.e., the positive deviance and parent facilitator training (physical rehabilitation) strategies, to malnutrition and care-giving among children and youth with CP in eastern Uganda.
Study Objective: To determine the difference in the effectiveness of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and youth with cerebral palsy in the Iganga Mayuge and Bugweri districts.
Study setting: The study will be conducted within the districts of Iganga, Mayuge and Bugweri in eastern Uganda.
Study design: This will be a 2x2 factorial quasi-randomised controlled trial assessing the effects of the Positive deviance (PD) (Yes/No) and Parent facilitator training (PFT) (Yes/No) strategies within four experimental conditions: i) Both PD and PFT, ii) Only PD, iii)Only PFT, iv) Neither PD and nor PFT(controls).
Study population: The study population will include caregivers of malnourished children and youth aged 2-24 years old with a confirmed diagnosis of CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This will be a 2x2 factorial quasi-randomised controlled trial assessing the effects of the Positive deviance (PD) (Yes/No) and Parent facilitator training (PFT) (Yes/No) strategies within four experimental conditions: i) Both PD and PFT, ii) Only PD, iii)Only PFT, iv) Neither PD and nor PFT(controls).
| Arm | Type | Receives |
|---|---|---|
| Positive deviance (PD) | Experimental | Behavioral: positive deviance hearth strategyThis group will receive only the positive deviance intervention and not the PFT |
| Parent facilitator training (PFT) | Experimental | Behavioral: Parent facilitator trainingsThis group will receive only the parent facilitator training intervention and not the PD |
| Parent facilitator and positive deviance(PFT/PD) | Experimental | Behavioral: positive deviance hearth strategy, Behavioral: Parent facilitator trainingsThis group will receive both the PD and PFT interventions |
| Control | Active comparator | Other: ControlThis group will receive neither the PD nor the PFT interventions but care as usual. |
Who may qualify
- Ages
- 2 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Malnourished children and youth (<-2sd in any of height for age, weight for age and body mass index for age z-scores) with CP
- Caregivers of malnourished children and youth with CP
Key exclusion criteria (2 listed)
- Caregivers registered in other nutrition interventions
- severely malnourished children that require life-saving nutrition management
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 |
|---|---|---|
| positive deviance hearth strategyThe PD-program is run for 3-months with 2 weeks (12 days) of nutrition education and rehabilitation sessions (NERS) conducted in each month. Each day session includes an half hour education session and a one and half hour peer led cooking session. Caretakers learn how to rehabilitate their malnourished children under the supervision and the support of caregivers who have well-nourished children (positive deviants). Children are nutritionally assessed by trained nutrition assistants or clinician on the 1st day of the NERS sessions and after three months. During the rehabilitation sessions, caregivers learn how to prepare nutrient-rich meals for their children from locally available food identified during the positive deviance-inquiry, and actively practice good feeding and hygiene practices. Caregivers together prepare food menus based on the PD-inquiry good foods or what they can conveniently access but of equal nutritional value. | Behavioural | Parent facilitator and positive deviance(PFT/PD), Positive deviance (PD) |
| Parent facilitator trainingsPrimary caregivers of children with CP residing in the study setting are trained as parent facilitators by expert physical rehabilitation therapist . Trained parent facilitators then hold fellow caregiver workshops each lasting approximately two hours long and includes between 6-10 caregivers. To ensure quality and consistency of the workshops, the Parent Facilitators follow a detailed manual adapted from the Carer-2-Carer Programme translated into Lusoga, the local language. No expert therapists is involved in the parent facilitator training workshops. Parent facilitator training workshops involve 7 sessions that expose caregivers to understanding CP and how to improve body functioning: session1: what is CP? session2: CP as a way of life, Session 3: Getting my child's body ready to move, Session 4: Eating and drinking a healthy diet, Session 5: communication, Session 6: Play, and Session 7: Central visual impairment. | Behavioural | Parent facilitator and positive deviance(PFT/PD), Parent facilitator training (PFT) |
| ControlThis group will receive neither the PD nor the PFT interventions but care as usual | Other | Control |
Primary outcome
Nutritional status
Time frame: 3 months
Mean weight gain
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 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive deviance hearth strategy and Parent facilitator trainings in people with Weight Gain, run by Makerere University at 1 site in Uganda.
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 2 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Nutritional status (time frame: 3 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 Feb 2023.