ISRCTN89011056已完成未知
An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga (HRWP); a randomised controlled trial of a dietary pattern in adults at metabolic risk and their whanau and the effect on metabolic syndrome z score
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38148791/ (added 27/12/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39131736/ (added 14/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For index individuals:
- •1. Adults aged 18-70 years
- •2. Metabolic syndrome severity z-score (MetS-Z) >0.35
- •3. In addition to the index individual, a minimum of one other whanau member in the household agrees to participate (these additional household members, if they qualify, may also be enrolled as an index individual). Up to five whanau are eligible to take part
- •4. Participants and their whanau are planning to live together for the duration of the study
- •5. Access to the internet at home
- •6. Able and willing to attend all site visits
- •7. Is willing to adhere to local health and safety regulations
- •8. For the consumer insights study there needs to be a willingness to be interviewed
- •For household/whanau members:
- •1. Living in the same household as the index individual
- •2. Consent/assent to consume the intervention diet
- •All household/whanau members who qualify for inclusion will: a) complete age-appropriate questionnaires; b) be invited to undertake clinical measurements; and c) be invited to provide blood samples if aged 11 years and over.
排除标准
- •For index individuals:
- •1. Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of type 2 diabetes mellitus (T2DM) is uncertain, this will be defined as ever having had two consecutive HbA1c results greater than or equal to 50 mmol/mol that are at least 3 months apart
- •2. Total cholesterol greater than or equal to 8 mmol/l
- •3. Chronic severe renal disease (eGFR <30 ml/min/1.72m²)
- •4. Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
- •5. Unstable body weight (active weight loss/gain >5 kg in the prior 3 months)
- •6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy)
- •7. Severe food allergies (anaphylaxis) or intolerances in any household member
- •8. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
- •9. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
- •10. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
- •11. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part
- •For household/whanau members (blood samples):
- •1. Age <11 years
- •2. Pre-existing Type 1 diabetes
- •3. Chronic severe renal disease (eGFR <30 ml/min/1.72 m²)
- •4. Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
- •5. Unstable body weight (active weight loss/gain >5 kg in prior 3 months)
- •6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy)
- •7. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
- •8. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
- •9. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
- •10. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part
- •11. Children living in the household but who do not have a legal guardian also living in the household
- •12. Severe food allergies (anaphylaxis) or intolerances in any household member
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