ACTRN12622000906752招募中未知
An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga; 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
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria: For index individual
- •Adults aged 18-70 years
- •Metabolic syndrome severity z-score (MetS-Z) >0.35.
- •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 5 whanau are eligible to take part
- •Participants and their whanau are planning to live together for the duration of the study
- •Access to the internet at home
- •Able and willing to attend all site visits
- •Is willing to adhere to local health and safety regulations
- •For the consumer insights study there needs to be a willingness to be interviewed
- •Inclusion Criteria: For household/whanau members
- •Living in the same household as the index individual
- •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 individual
- •Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of 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 three months apart
- •Total cholesterol greater than or equal to 8 mmol/L
- •Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
- •Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
- •Unstable body weight (active weight loss/gain greater than 5 kg in prior three months)
- •Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy).
- •Severe food allergies (anaphylaxis) or intolerances in any household member
- •Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
- •Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
- •Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
- •Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part.
- •Exclusion criteria for provision of blood samples: For household/whanau members
- •Age less than 11 years
- •Pre-existing Type 1 diabetes.
- •Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
- •Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
- •Unstable body weight (active weight loss/gain greater than 5 kg in prior three months)
- •Gastrointestinal disorder that alters the digestion and absorption of nutrients (E.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy).
- •Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
- •Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
- •Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
- •Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part
- •Children living in the household but who do not have a legal guardian also living in the household
- •Severe food allergies (anaphylaxis) or intolerances in any household member
研究者
相似试验
尚未招募
不适用
The Healthy NZ Foods Pilot Study for Adults with Metabolic SyndromeMetabolic SyndromeDiet and Nutrition - ObesityMetabolic and Endocrine - Metabolic disordersObesityACTRN12621000856819Capital and Coast District Health Board30
已完成
不适用
An Aotearoa New Zealand diet for metabolic health and whanau wellbeing: He Rourou Whai PaingaMetabolic syndromeNutritional, Metabolic, EndocrineISRCTN89011056niversity of Otago200
尚未招募
不适用
utritional biomarkers comparing a healthy versus a typical Australian diet: a Feeding Study in Australian Adults.Diet-related cardiovascular diseaseCardiovascular - Other cardiovascular diseasesDiet and Nutrition - Other diet and nutrition disordersACTRN12622001321730niversity of Newcastle40
已完成
不适用
Optimising patient weight management prior to joint replacement to improve outcomes: a feasibility study with embedded qualitative componentDiet and Nutrition - ObesityMusculoskeletal - Osteoarthritiship osteoarthritisknee osteoarthritisobesityACTRN12619000682145South West Sydney Local health District97
已完成
不适用
Investigating the Nutritional Status of New Zealand Adults in Residential Aged-Care: the New Zealand Nutrition in Aged-care Project (NZNAPs)utrition StatusAgeingACTRN12617001575325Associate Professor Lisa Houghton320