- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283332
Determinants of Adolescent, Now Young Adults, Social Well-being and Health: Longitudinal Follow-up (DASH)
Determinants of Adolescent Social Well-being and Health: a London Based Longitudinal Study of Young People From Different Ethnic Groups
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Black and ethnic minority groups living in the UK experience high rates of chronic diseases such as diabetes, hypertension and heart disease, general morbidity and poor mental health. The cause of these excess rates is unknown but obesity, smoking, diet and deprivation are important contributing factors. There is also global evidence of the association of these diseases in adulthood with health and deprivation in early life and childhood. Persisting social deprivation over the lifecourse is disproportionately borne by some ethnic minorities (Harding and Balarajan 2001) but the impact on the health of their children is virtually unknown. Least is known about the health of Black Caribbean young people. It is important to examine risk factor differences by social predictors within the ethnic minority groups as well as between them. The DASH Study started as a school-based cohort study of adolescents from the main ethnic groups (White British, Black Caribbean, Black African, Indian, Pakistani and Bangladeshi) in 10 London boroughs. Wave 1 took place in 2002/03 (MREC Ref: MREC/2/10/12), when participants were aged 11-13 years (school years 7 and 8). Wave 2 took place in 2005/06 (MREC Ref: 05/MRE10/43) when they were 14-16 years (school years 9 and 10). Wave 3 took place in 2010/2011, when participants were aged 19-21 years and involved a postal follow-up complemented by telephone interview and on-line questionnaires. The current proposal is for a feasibility study, using a small sample of the DASH cohort, to inform the design of the next full face-to-face follow-up. DASH will be the first large scale UK longitudinal cohort of ethnic minority youths with both social and biological measures from childhood to early adulthood. It will allow detailed examination of ethnic differences in the social patterning of biological mechanisms and pre-clinical disease in young adulthood.
Aims:
(i) To conduct a feasibility study to establish the best methods for data collection, including the collection of physical and biological measurements, for subsequent face to face follow-up of the entire cohort.
(ii) To generate a proposal for subsequent follow-up of the entire cohort for submission to MRC, dependent on the findings of the postal and telephone surveys and proposed feasibility study.
Objectives:
I. What are the advantages and disadvantages of conducting the study in the two settings - GP surgeries and homes?
- Do participants' response rates vary by setting?
- What are the challenges faced by the nurses in clinics and home visits?
- Will the quality of data collected (e.g. extent of missing data) vary by setting?
- Will the delivery of blood samples to the laboratory be reasonably straight forward in each setting? II. What percentage of participants will agree to undertake bio-marker measures? III. Are mental health measures for this age group, typically used with White European populations, culturally appropriate? IV. How will DASH participants' view feedback on their medical results (e.g. blood pressure, weight, blood lipids)? V. Were participants satisfied with the different components of the survey process - contact, consent, data collection? VI. What is the estimated length of time and the resources required for subsequent full follow-up of DASH study members?
Outcome measures:
These will be examined by setting (home visit, GP surgery) using a mixture of quantitative and qualitative methods and are as follows:
I. Percentage response rates - overall, per item/physical measure; II. Percentage consistency of answers to questionnaire items; III. Percentage physical measures within expected range e.g. spirometric measures; IV. Mean length of time for interview; V. Mean length of time for taking physical/biological measures; VI. Qualitative appraisal of cultural appropriateness of mental health measures and of respondents' satisfaction with survey processes.
Sample At the recent telephone survey, respondents were asked if they would be willing to take part in a small feasibility study to prepare for a later full face to face follow-up. Almost all agreed and of those, a sample of 300 (40-50 in each of the main ethnic groups- White British, Black Caribbean, Black African, Pakistani, Bangladeshi, Indian) will be invited to complete a questionnaire, and have physical and physiological measures taken. Interviews will be conducted in respondents' own homes or GP surgeries dependent on the preference of the respondent. As this is a feasibility study, the sample size has been chosen pragmatically to give a reasonable spread, with equal gender representation across the 10 London boroughs that the whole sample was in at wave 2.
Specially trained nurses will conduct the survey in homes or General Practitioners' surgeries, supervised by a nurse manager in the General Practice Research Framework. Nurses will be attached either to the General Research Practice Framework or the Primary Care Research Network.
Main Questionnaire The content reflects mainly questions that were asked in previous waves (general health; health behaviours; psychological well-being; SEC; social support; and relationship with parents). New items include parenthood; age appropriate mental health measures; own education, economic activity and occupation; job strain; caring; 'romantic' relationships; positive and negative emotions; views on their parents being invited to participate in DASH in order to examine generational influences. The investigators will explore two methods of delivery of the questionnaires - self complete questionnaires done prior to visit and computer assisted interviews. If the questionnaire is not completed by the time of the interview, respondents will be asked if they would like to complete a computer assisted interview. Completion of the questionnaire is expected to take about 40 minutes.
Physical/physiological measures As in waves 1/and 2, height, weight, arm, waist and hip circumference, lung function, blood pressure will be measured.
New measures include:
(i)Hand to foot bio-impedance (ii) Bio-markers - HbA1c, total cholesterol, HDL-cholesterol (iii) Dietary assessment - 24 hour recall interviews Qualitative assessment - focus groups and semi-structured interviews. For the new mental health/cognitive measures, the investigators will conduct focus group vignette assessment, based on explanatory model and illness perception theories. This will be carried out in a small sub-sample (6 participants per ethnic group and allowing for 2 gender-specific groups; n=48). Analysis of these data will focus on narratives about the signs and symptoms of different aspects of mental health in the different ethnic groups. These data will provide valuable insights about the appropriateness of measures, usually validated with European populations, for ethnic minority groups.
A research scientist will conduct semi-structured interviews with respondents to obtain feedback on the process of follow-up - what worked well, how best to improve the process, what was un/acceptable etc. The investigators will also enquire about the usefulness of feedback of results. A similar evaluation will take place with the nurses with the aim of identifying best practice in clinics and homes.
Data analysis Descriptive statistics will be used to look at the general distributions and quality of the data collected. Outcomes measured as rates will be examined by data collection setting (GP surgeries vs. home visits), ethnic group and socio-demographic characteristics using standard comparisons technique such as Chi-square test or logistic regression. Mean length of time and any continuous outcomes will be compared using linear regression. In addition, although the sample size of each ethnic group is small, the total sample will allow analyses of the potential social patterning of biological mechanisms in a diverse sample in young adulthood.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- provision of informed consent
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: Through study completion, on average 10 years
|
Percentage response rates - overall, per item/physical measure
|
Through study completion, on average 10 years
|
Interview duration
Time Frame: Through study completion, on average 10 years
|
Mean length of time for interview
|
Through study completion, on average 10 years
|
physical measures duration
Time Frame: Through study completion, on average 10 years
|
Mean length of time for physical/biological measures
|
Through study completion, on average 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Through study completion, on average 10 years
|
Body weight, kg
|
Through study completion, on average 10 years
|
Height
Time Frame: Through study completion, on average 10 years
|
Height, cm
|
Through study completion, on average 10 years
|
waist circumference
Time Frame: Through study completion, on average 10 years
|
Waist circumference, cm
|
Through study completion, on average 10 years
|
blood pressure
Time Frame: Through study completion, on average 10 years
|
systolic and diastolic blood pressure, mmHg
|
Through study completion, on average 10 years
|
Body fat
Time Frame: Through study completion, on average 10 years
|
body fat measured by bioelectrical impedence, %
|
Through study completion, on average 10 years
|
HbA1c
Time Frame: Through study completion, on average 10 years
|
Glycated haemoglobin, %
|
Through study completion, on average 10 years
|
Total cholesterol
Time Frame: Through study completion, on average 10 years
|
Serum total cholesterol, mmol/l
|
Through study completion, on average 10 years
|
HDL-cholesterol
Time Frame: Through study completion, on average 10 years
|
Serum high-density-lipoprotein cholesterol, mmol/l
|
Through study completion, on average 10 years
|
Energy intake
Time Frame: Through study completion, on average 10 years
|
Dietary energy intake, kcal/day
|
Through study completion, on average 10 years
|
Fat intake
Time Frame: Through study completion, on average 10 years
|
Dietary fat intake, % of total energy intake
|
Through study completion, on average 10 years
|
Saturated fat intake
Time Frame: Through study completion, on average 10 years
|
Dietary saturated fat intake, % of total energy intake
|
Through study completion, on average 10 years
|
Carbohydrate intake
Time Frame: Through study completion, on average 10 years
|
Dietary carbohydrate intake, % of total energy intake
|
Through study completion, on average 10 years
|
Sugar intake
Time Frame: Through study completion, on average 10 years
|
Dietary sugar intake, g/day
|
Through study completion, on average 10 years
|
Fibre intake
Time Frame: Through study completion, on average 10 years
|
Dietary fibre intake, g/day
|
Through study completion, on average 10 years
|
Sodium intake
Time Frame: Through study completion, on average 10 years
|
Dietary sodium intake, mg/day
|
Through study completion, on average 10 years
|
Skipping breakfast
Time Frame: Through study completion, on average 10 years
|
Questionnaire measure of regularity of skipping breakfast
|
Through study completion, on average 10 years
|
Fruit intake
Time Frame: Through study completion, on average 10 years
|
Questionnaire measure of regularity of fruit consumption
|
Through study completion, on average 10 years
|
Vegetable intake
Time Frame: Through study completion, on average 10 years
|
Questionnaire measure of regularity of vegetable consumption
|
Through study completion, on average 10 years
|
Fizzy drink intake
Time Frame: Through study completion, on average 10 years
|
Questionnaire measure of regularity of fizzy drink consumption
|
Through study completion, on average 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seeromanie Harding, PhD, King's College London
Publications and helpful links
General Publications
- Harding S, Whitrow M, Maynard MJ, Teyhan A. Cohort profile: The DASH (Determinants of Adolescent Social well-being and Health) Study, an ethnically diverse cohort. Int J Epidemiol. 2007 Jun;36(3):512-7. doi: 10.1093/ije/dym094. Epub 2007 Jul 30. No abstract available.
- Lu Y, Sooky L, Silva MJ, Molaodi OR, Karamanos A, Cruickshank JK, Harding S. Longitudinal study of the influence of lung function on vascular health from adolescence to early adulthood in a British multiethnic cohort. J Hypertens. 2017 Nov;35(11):2185-2191. doi: 10.1097/HJH.0000000000001455.
- Harding S, Silva MJ, Molaodi OR, Enayat ZE, Cassidy A, Karamanos A, Read UM, Cruickshank JK. Longitudinal study of cardiometabolic risk from early adolescence to early adulthood in an ethnically diverse cohort. BMJ Open. 2016 Dec 14;6(12):e013221. doi: 10.1136/bmjopen-2016-013221.
- Faconti L, Silva MJ, Molaodi OR, Enayat ZE, Cassidy A, Karamanos A, Nanino E, Read UM, Dall P, Stansfield B, Harding S, Cruickshank KJ. Can arterial wave augmentation in young adults help account for variability of cardiovascular risk in different British ethnic groups? J Hypertens. 2016 Nov;34(11):2220-6. doi: 10.1097/HJH.0000000000001066.
- Harding S, Read UM, Molaodi OR, Cassidy A, Maynard MJ, Lenguerrand E, Astell-Burt T, Teyhan A, Whitrow M, Enayat ZE. The Determinants of young Adult Social well-being and Health (DASH) study: diversity, psychosocial determinants and health. Soc Psychiatry Psychiatr Epidemiol. 2015 Aug;50(8):1173-88. doi: 10.1007/s00127-015-1047-9. Epub 2015 Apr 11.
- Whitrow MJ, Harding S. Asthma in Black African, Black Caribbean and South Asian adolescents in the MRC DASH study: a cross sectional analysis. BMC Pediatr. 2010 Mar 25;10:18. doi: 10.1186/1471-2431-10-18.
- Harding S, Teyhan A, Maynard MJ, Cruickshank JK. Ethnic differences in overweight and obesity in early adolescence in the MRC DASH study: the role of adolescent and parental lifestyle. Int J Epidemiol. 2008 Feb;37(1):162-72. doi: 10.1093/ije/dym252. Epub 2008 Jan 19.
- Maynard MJ, Harding S, Minnis H. Psychological well-being in Black Caribbean, Black African, and White adolescents in the UK Medical Research Council DASH study. Soc Psychiatry Psychiatr Epidemiol. 2007 Sep;42(9):759-69. doi: 10.1007/s00127-007-0227-7. Epub 2007 Jun 29.
- Harding S, Maynard MJ, Cruickshank K, Teyhan A. Overweight, obesity and high blood pressure in an ethnically diverse sample of adolescents in Britain: the Medical Research Council DASH study. Int J Obes (Lond). 2008 Jan;32(1):82-90. doi: 10.1038/sj.ijo.0803662. Epub 2007 Jun 19.
- Harding S, Maynard M, Cruickshank JK, Gray L. Anthropometry and blood pressure differences in black Caribbean, African, South Asian and white adolescents: the MRC DASH study. J Hypertens. 2006 Aug;24(8):1507-14. doi: 10.1097/01.hjh.0000239285.20315.4d.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 05/MRE10/43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The DASH data are available to researchers via a data request to the MRC Social and Public Health Science Unit. Applications and the data sharing policy for DASH can be found at http://dash.sphsu.mrc.
ac.uk/DASH_dsp_v1_November-2012_draft.pdf. It reflects the MRC guidance on data sharing with the aim of making the data as widely and freely available as possible while safeguarding the privacy of participants, protecting confidential data, and maintaining the reputation of the study. All potential collaborators work with a link person, an experienced DASH researcher-to support their access to and analysis of the data. The variable-level metadata is available from the study team and also via the MRC Data Gateway.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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