Growth in adolescence: Potential interventions to improve growth and health and reduce the risks of future non-communicable disease

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN43582765
• Date of registration: 01/09/2016
• Prospective Registration: No
• Primary sponsor: London School of Hygiene and Tropical Medicine (LSHTM)
• Public title: Growth in adolescence: Potential interventions to improve growth and health and reduce the risks of future non-communicable disease
• Scientific title: Growth in Adolescence: Potential interventions to improve growth and health and reduce the risks of future non-communicable disease: a cross-sectional pilot survey and interview study to inform a future RCT
• Date of first enrolment: 24/08/2016
• Target sample size: 780
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN43582765
• Study type: Observational
• Study design: Formative, mixed-methods, pilot study (Quality of life)

Countries of recruitment

Malawi

Contacts

• Name: Marko Kerac

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adolescents aged 10-19 years
2. Both males and females
3. Living in Karonga district or Lilongwe Area 25
Exclusion criteria: 1. Visiting adolescents who do not live in the catchment area
2. Adolescents who do not have full consent to participate in the study
3. Adolescents with a disability that means a height measure cannot be obtained

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

1. Stunting 2. Increased risk of future non communicable disease (NCD)
Nutritional, Metabolic, Endocrine

Intervention(s)

This observational research will take place in Karonga (rural site) and a Lilongwe (urban Site) in Malawi and will consist of:
1. Qualitative research: Key informant interviews with future study stakeholders will be conducted. Mainly individual interviews and some small focus groups. Approx. 20 individuals per study group are expected to achieve data saturation for interviews, and a maximum of 10 focus groups with a minimum of 4 participants.
2. A cross sectional survey: the primary aim of this is determine prevalence of stunting in adolescents in these communities. This will include primary data collection in Lilongwe, recruiting approx. 600 adolescents; and secondary data analysis in Karonga where basic anthropometry for all adolescents is already available
3. A detailed quantitative survey nested within the prevalence survey: More in-depth assessment of approximately 200 adolescents at each site will be conducted, including: a detailed questionnaire asking about possible risk factors for stunting/adverse long term outcomes; detailed anthropometry (following WHO recommended measurement methods); assessment of physical activity (using accelerometers); cognitive function (using CANTAB cognitive testing); and body composition by Bioelectrical Impedance Analysis or BIA (using Bodystat 1500MDD at 50Khz).

Study questionnaires are based on existing validated tools including used in the Global School Heath Survey (GSHS), the Malawi Demographic Health Survey (DHS) and the FAO (Food and Agriculture Organization) 24 hour food recall sheet.

Pubertal stage will be self-assessed using Tanner staging.

The main target population are adolescents aged 10-19 years. In the qualitative sub-study carers/parents; teachers; community healthcare workers; other community leaders will also be interviewed.

Primary Outcome(s)

1. Prevalence of stunting defined as height-for-age z score <-2 based on WHO 2007 Growth Standards, in adolescents aged 10-19 years in study communities in Karonga and Area 25 of Lilongwe
2. Views of adolescents on design of a future intervention assessed through qualitative interviews
3. Baseline means and standard deviations for:
3.1. Steps per day measured with Actilife accelerometers worn for 48 hours
3.2. Key CANTAB (cognitive function) outcomes, as dictated by the manufacturers, from a battery of 6 tests: Motor Screening Task (MOT), Paired Associates Learning (PAL), Pattern Recognition Memory (PRM), Reaction Time (RTI), Emotion Recognition Task (ERT) and Spatial Span (SSP)
3.3. Resistance, Reactance, Impedance Index and Phase angle measured by BIA device
3.4. Hand grip strength measured as the best of 3 attempts on each hand

Secondary Outcome(s)

1. Intra-cluster correlation coefficient for HAZ (height-for-age z-score),steps per day, CANTAB outcomes, BIA outcomes and hand grip strength.
2. Views of parents, community leaders and relevant professionals on the design of a future intervention assessed though qualitative interviews
3. Risk factors for stunting, poor health and NCDs in this population including:
3.1. Blood pressure
3.2. Nutritional intake measured using FAO 24 hour food recall method
3.3. Waist/hip circumference ratio
3.4. Sitting height
3.5. Behaviour and hygiene factors measured using standard questions from WHO Global school-based student health survey (GSHS)
3.6. Socioeconomic status calculated using principal components analysis (PCA) of standard asset questions from the Malawi Demographic Health Survey (DHS)
4. Mean difference between main outcomes (CANTAB outcomes, steps per day, BIA outcomes and handgrip strength) between stunted and non-stunted individuals

Secondary ID(s)

200669/Z/16/Z

Source(s) of Monetary Support

Wellcome Trust