None listed
Conditions
Brief summary
This is a multi-centre, randomised controlled trial of food provision and dietary change support compared with habitual dietary intake for 12 weeks. The group randomised to the habitual dietary intake will subsequently receive the food provision and dietary change support. In all participants, the 12-week intervention of food and support will be followed by a secondary randomisation to receive continued dietary change support for a further 12 weeks or enter directly into an observational maintenance phase. This will be followed by a longitudinal observational follow up of all participants out to a total of 52 weeks from the initiation of the intervention. Therefore, the overall design is a combination of a 12-week randomised controlled trial and a 12-month longitudinal observation study incorporating a randomised controlled trial of dietary change support. Two hundred index participants at risk of cardiovascular and metabolic disease will be recruited, and each participant can invite up to five members of their household/whanau into the study, To understand participants’ experiences in this study, a fully integrated qualitative consumer insights study will be undertaken concurrently to the other assessments. The purpose of this part of the study is to gain insight into the perceptions, attitudes and emotions of participants and to corroborate behavioural data gained in the quantitative study with respect to the adoption and maintenance of the intervention diet.
Interventions
This is a randomised controlled trial of food provision and dietary change support (Group B) compared with habitual dietary intake (Group A) for 12 weeks. Index participants will be adults at risk of metabolic and cardiovascular disease and up to 5 members of their household/whanau can be invited to also take part in the study. The intervention itself (food provision and dietary change support) is delivered over a period of 12 weeks. Participants and their household/whanau will receive the food at their homes on a weekly and/or fortnightly basis. The dietary change support will be available online at all times through the intervention. The food provision means that participants and their household/whanau will receive up to 75% of their weekly food delivered to their home for 12 weeks. The food, which together forms a dietary pattern, is rich in fruit, vegetables, wholegrains, legumes, olive oil and seafood. The food deliveries will be arranged by the researchers directly with the food delivery companies, and any issues with deliveries will be reported by the food delivery companies to the researcher who will be able to rectify any issues. The specific foods and meals to be delivered may vary depending on availability of items but will all fit within the dietary pattern to be tested. Whether the food deliveries are weekly or fortnightly will not affect the consistency of the intervention delivered across the time period of the intervention. The dietary change support includes a participant-facing study website with guidance on how to change dietary behaviour, recipes and meals plans, information about the food provided and about the metabolic syndrome. The support includes access to Facebook groups and peer-support online activities. The online support is designed and delivered by research dietitians with a minimum of 5 years’ experience. It is at the participant’s discretion how much time they spend interacting with the dietary change support website and online community groups. Peer-support activities will include posts/polls on the Facebook page that encourage participants to share ideas, recipes and ask questions e.g. peer support online activities such as sharing pictures of meals made with the provided food, asking participants to identify current challenges and develop ideas on overcoming these challenges. Some of the resources on the participant-facing website have been designed specifically for this study. On this website, the information will be presented in categories e.g. shopping/cooking tips. This category, for instance, will contain links to videos created specifically for this study which are hosted on websites such as youtube, as well as content from other websites e.g. recipes from Heart Foundation New Zealand. Other resources may include down-loadable fact sheets and participant-friendly articles. Participants may also be directed towards the following websites, among others websites and resources: Meal planning tips video: https://www.youtube.com/watch?v=sqqFzqLFmoY Meal planning article: https://lovefoodhatewaste.co.nz/meal-planning/ Meal Planner: https://www.lovefoodhatewaste.nsw.gov.au/sites/default/files/2020-09/LFHWMenuPlannerListColour%20210920.pdf Heart Foundation Recipes: https://www.heartfoundation.org.nz/wellbeing/healthy-recipes Chopping onion: https://www.youtube.com/watch?v=dCGS067s0zo Chopping garlic: https://www.youtube.com/watch?v=tDfCdkGivdA Storing food in fridge: https://www.heart.org/en/healthy-living/healthy-eating/cooking-skills/storing/using-your-fridge-the-right-way Food portions print out https://assets.heartfoundation.org.nz/documents/shop/nutrition/docs/food-portions-a4.pdf Food swaps: https://www.youtube.com/watch?v=Onyc0tTogsw&t=59s In both groups, the 12-week intervention phase will be followed by a secondary randomisation to receive continued dietary change support for a further 12 weeks or entry directly into an observational maintenance phase. During this 12-week period, those participants randomised to receive continued dietary change support will have continued access to the website and online platform only. This period will be followed by a longitudinal observational follow up of all participants out to a total of 52 weeks from the initiation of the intervention diet. The research visits will take place in four research centres across New Zealand. Depending on whether participants have been randomised to Group A or Group B determines how many times they and their household/whanau participants will visit the research; either 5 or 6 times. Each visit will last approximately 1-4 hours, depending on the measurements to be undertaken at that visit. Visits will take place virtually or in the participant's homes if regulations specify this at the time. Intervention adherence will be measured through the collection of dietary intake data and the assessment of it against a Mediterranean diet score. In addition, to understand participants’ experiences in this study, a fully integrated qualitative consumer insights study will be undertaken concurrently to the other assessments. The purpose of this part of the study is to gain insight into the perceptions, attitudes and emotions of participants and to corroborate behavioural data gained in the quantitative study with respect to the adoption and maintenance of the intervention diet. This component is delivered by experts in qualitative research methodology with greater than 5 years’ experience.
Sponsors
Study design
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 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