Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003117129 Date of Approval: 20/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of nutrition counseling on weight gain and nutrition intake in children with cerebral palsy in Tanzania
Official scientific title Effect of nutrition counseling intervention on nutritional intake among children with cerebral palsy attending cerebral palsy clinic at Muhimbili National Hospital, in Dar es Salaam; A hospital-based, non-blinded, randomized controlled trial
Brief summary describing the background and objectives of the trial Children with CP have been reported to experience high prevalence of feeding difficulties that is associated with type and severity and has negative effect on nutritional status. At Muhimbili National Hospital (where this study is conducted) it is estimated that 73% of children attending CP clinic have malnutrition. Improved nutrition has a positive impact on any child¿s health. Studies have shown that an elevation in intake of energy food in children with cerebral palsy induces catch-up growth. However, majority of children with cerebral palsy and their families living in low-income countries generally receive inadequate nutritional counselling and educational services in the community and hospital. Lack of nutritional counselling and educational services on feeding practices may contribute to the high prevalence of malnutrition in children with cerebral palsy in Tanzania. This increases the health care burden to their families, hospital and the nation due to prolonged hospitalization. Using a non-blinded randomized-control intervention study we assessed the effectiveness of a nutrition counselling intervention on weight gain and nutrient intake among children with cerebral palsy attending a clinic in urban Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CP
Disease(s) or condition(s) being studied Cerebral Palsy,Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 05/02/2013
Actual trial start date 03/02/2014
Anticipated date of last follow up 31/07/2018
Actual Last follow-up date 22/08/2018
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 110
Recruitment status Completed
Publication URL 10.1111/cch.12553
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book was used to select random numbers for participants selection. This was done by a separate person who is unaware of the study Children were allocated to the intervention or control group using a random digit table. This was applied to the participants ID that was distributed sequentially as they were being recruited. The PI regularly checked the randomization process (proper use of the random digit table to allocate intervention) to ensure that the study protocol was being adhered to Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition counseling and physiotherapy 6 sessions of nutrition counseling and physical training on feeding positioning on weekly basis 6 months Nutrition education and counseling; physical training on feeding position, feeding methods and feeding practices 63
Control Group Routine CP treatment care General care on weekly for physio and occupational therapy and monthly on CP dose prescription 6 months Children were provided with general care for physio and occupational therapy, physical and nutritional assessment. At the end of 6 months they received a brief teachings and demonstrations of the intervention contents provided to intervention group 47 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children diagnosed with CP as documented in their medical records and attending CP clinic at MNH. 2. Children with cerebral palsy who have been identified as having feeding difficulties. 3. Children whose parents/caregivers gave written informed consent to participate in the study. 4. Children of parents/caregivers who attended CP clinic at MNH during study period 1. Children with other chronic illness such as HIV, Cardiovascular and kidney disorders 2. Congenital malformations that affect food intake like cleft lip and/or palate. 3. Children who were eligible during enrollment but developed chronic illness during intervention and be replaced. 4. Children who were eligible during enrollment but did not attend for several appointments were excluded and replaced. 6 Month(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/12/2012 Muhimbili University of Health and Allied Sciences; University research committee
Ethics Committee Address
Street address City Postal code Country
United Nations Rd Dar es Salaam 25522 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in weight gain Primary outcome anticipated a ¿ weight gain increase of 1.15kg or above after 6 months
Secondary Outcome Proportion of caregivers and children with improved feeding skills (2) proportion of improved caregiver-child relationship during feeding Baseline, and after 6 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhimbili National Hospital Kalenga Street; Maliki Road plot number 1048 Dar es Salaam 25522 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
SIDA through MUHAS capacity building strengthening program United Nations Rd, Dar es Salaam Dar es Salaam 25522 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SIDA through MUHAS capacity building strengthening program United Nations Rd, Dar es Salaam Dar es Salaam 25522 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Muhimbili National Hospital Kalenga street, Maliki Road Plot number 1048 Dar es Salaam 25522 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Scholastica James Mlinda scholajm@gmail.com +255-717-918082 Kalenga Street, Maliki Road, plot number 1048
City Postal code Country Position/Affiliation
Dar es Salaam 25522 United Republic of Tanzania Nutritionist
Role Name Email Phone Street address
Public Enquiries Scholastica James Mlinda scholajm@gmail.com +255-717-918082 Kalenga Street, Maliki Road, plot number 1048
City Postal code Country Position/Affiliation
Dar es Salaam 25522 United Republic of Tanzania Senior nutritionist
Role Name Email Phone Street address
Scientific Enquiries Germana Henry Leyna gerryleyna@yahoo.com +255-782-847320 United Nations Road,
City Postal code Country Position/Affiliation
Dar es Salaam 25522 United Republic of Tanzania Co-Supervisor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information