Caregiver Led Strategies to Malnutrition and Care-giving Among Children With Cerebral Palsy

NCT05592834 | Completed

• 1 other identifier: HDREC 186
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

• Nutritional status

  Mean weight gain

  3 months

Study Arms (4)

Positive deviance (PD)

EXPERIMENTAL

This group will receive only the positive deviance intervention and not the PFT

Behavioral: positive deviance hearth strategy

Parent facilitator training (PFT)

EXPERIMENTAL

This group will receive only the parent facilitator training intervention and not the PD

Behavioral: Parent facilitator trainings

Parent facilitator and positive deviance(PFT/PD)

EXPERIMENTAL

This group will receive both the PD and PFT interventions

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.

Other: Control

Interventions

positive deviance hearth strategy BEHAVIORAL

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 and positive deviance(PFT/PD); Positive deviance (PD)

Parent facilitator trainings BEHAVIORAL

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.

Parent facilitator and positive deviance(PFT/PD); Parent facilitator training (PFT)

Control OTHER

This group will receive neither the PD nor the PFT interventions but care as usual

Control

Eligibility Criteria

• Age: 2 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Caregivers registered in other nutrition interventions
• severely malnourished children that require life-saving nutrition management

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Makerere University School of Public Health

Kampala, 7072, Uganda

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Evaluators, Participants, and caregivers facilitating the PFT and PD training sessions will be blinded on group allocations. A group of independent outcome assessors (evaluators), not involved in the intervention, will administer the outcome measures after the interventions. These evaluators will also be blinded to group allocation to avoid reporting bias.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: August 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 17, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

UG (1)