Trial document





This trial has been registered retrospectively.
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  DRKS00013767

Trial Description

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Title

ADAPT – Feasibility study of a culturally adapted, family-based dietary intervention for weight-loss among Ghanaian migrants

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Trial Acronym

ADAPT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

People from Ghana and other Africans living in Europe seem to develop diabetes more frequently than Europeans. We know that overweight can increase the risk of diabetes among Ghanaians living in Europe. We have learned that eating habits and physical activity are important reasons for overweight and diabetes. Therefore, a Ghana-specific diet and sports programme might help to lose weight and to reduce diabetes risk for Ghanaians in Berlin.
For this reason, we want to find answers in our study:
- How do Ghanaians in Berlin like the Ghana-specific diet and sports programme?
- To what extent does the diet and sports programme improve your health?

For this study, we want to include 5 Ghanaian men and 5 Ghanaian women living in Berlin. The information which we thereby collect will help to understand how we can improve the Ghana-specific diet and sports programme for Ghanaians living in Berlin and elsewhere. This knowledge is needed to ask more Ghanaians to enrol in the diet and sports programme for weight-loss and better health among Ghanaians and other Africans.

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Brief Summary in Scientific Language

ADAPT constitutes a social-medical feasibility study addressing the growing group of West-African migrants in Germany, who are at increased risk of general and abdominal obesity – an important risk factor for metabolic diseases. Established migrant groups in Germany fail to respond to conventional dietary modifications for weight-loss. Evidence from African Americans and Asian migrants in Europe emphasize the importance of cultural adaptations for weight-loss programs. So far, such approaches are lacking for migrants from West-Africa residing in Germany, and established strategies for African Americans may not be transferrable because of linguistic, educational and migration-related peculiarities. Various frameworks are proposed for cultural adaptations, including peripheral, evidential, linguistic, constituent-involving and socio-cultural strategies. Yet, the relative contributions of these strategies to the success of culturally adapted dietary weight-loss interventions remain to be clarified.

Thus, we conduct a feasibility study to evaluate the practicability and the acceptability of a culturally adaptated 3-months weight-loss intervention according to the German treatment guidelines for adiposity among well-characterized West-African adults in Berlin. Secondly, we aim at investigating changes in metabolic and anthropometric markers following weight-loss, and refining the study protocol to be applied in a cluster-randomized intervention.

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Organizational Data

  •   DRKS00013767
  •   2018/02/06
  •   [---]*
  •   yes
  •   Approved
  •   EA1/151/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66 -  Obesity
  •   E10-E14 -  Diabetes mellitus
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Interventions/Observational Groups

  •   Culturally adapted, family-based lifestyle intervention with the aim of weight-loss over a period of 3 months: First, the participants will receive a dietary counselling by an ethnically matched dietician and including culturally adapted print material. The latter will be given to the participants as a poster for domestic use. In intervals of 3 weeks, the participants will experience 3 cooking sessions at home and together with their “family cook”. The main aspects comprise portion sizes, food knowledge, seasonality of foods, healthy snacks that are low in energy content, and regular physical activity. In the beginning of the intervention, at midway and at the end of the intervention, 24-h dietary recall protocols will be taken by trained study personnel to collect information on dietary changes. Also, we will interview the participants on the acceptability of the intervention at midway and at the end. For monitoring and self-contracting of the participants, we will measure physical activity 3 times for each 1 week by accelerometry (ActivPAL).
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

feasibility and acceptance will be measured by questionnaire-based interviews

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Secondary Outcome

The changes in the outcomes weight status, metabolic biomarkers, blood lipids and blood pressure will be examined as follows:
- Measurements of body weight by a personal scale and of waist circumference by a measuring tape at the beginning and at the end of the study course (after 3 months)
- Fasting blood sampling and laboratory analysis of glucose markers (fasting glucose, HbA1c) and of blood lipids (triglycerides, total cholesterol, HDL, LDL) at the beginning and at the end of the study course (after 3 months)
- Oral glucose tolerance tests (oGTT) with blood sampling at T1=0 min, T2= 30 min, T3=120 min to measure blood glucose, insulin, C-peptide at the beginning and at the end of the study course (after 3 months)
- Semi-automated measurements of systolic and diastolic blood pressure and heart rate (OMRON) in triplicates and in intervals of 3 minutes with suitable cuffs and after an appropriate resting time at the beginning and at the end of the study course (after 3 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/02
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Inclusion Criteria: Participants of the previous RODAM study, at least 18 years of age, Ghanaian and overweight or obesity (BMI >=25.0 kg/m2)

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Exclusion Criteria

Exclusion Criteria: Pregnant women and known Type 2 Diabetes Mellitus patients

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Addresses

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    • Deutsches Institut für Ernährungsforschung PotsdamRehbrücke (DIfE)
    • Ms.  Dr  Ina  Danquah 
    • Abteilung Molekualre Epidemiologie Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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    • Institut für Tropenmedizin und Internationale Gesundheit, Charité – Universitätsmedizin Berlin (IfT)
    • Mr.  Prof. Dr.  Frank  Mockenhaupt 
    • Augustenburger Platz 1
    • 13353  Berlin
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    • Deutsches Institut für Ernährungsforschung PotsdamRehbrücke (DIfE)
    • Ms.  Dr  Ina  Danquah 
    • Abteilung Molekualre Epidemiologie Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Deutsches Institut für Ernährungsforschung PotsdamRehbrücke (DIfE)
    • Ms.  Dr  Ina  Danquah 
    • Abteilung Molekualre Epidemiologie Arthur-Scheunert-Allee 114-116
    • 14558  Nuthetal
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Diabetes Stiftung (DDS)
    • Mr.  Prof. Dr.  Rüdiger  Landgraf 
    • Staffelseestr. 6
    • 81477  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/18
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.