A primary care-led weight management intervention for adults with type 2 diabetes and obesity: DiRECT to Aotearoa New Zealand

DiRECT arm: The intervention arm will be usual care for those seeking to lose weight in New Zealand as well as a very low energy diet and weight loss maintenance phase delivered by a trained Dietitian at one medical centre (Te Kaika Health) in Caversham, Dunedin. Usual care includes weight loss advice, meal ideas, and lifestyle strategies delivered within the primary care service. The protocol for this intervention is the DiRECT protocol applied in the UK. Briefly, the first three months is an active weight loss phase of total diet replacement. This is the consumption of 3-4 meal replacements per day providing approx. 3600 kJ/day using Cambridge Weight Plan products. These meal replacement products come in a range of sweet and savoury, and may be made up into shakes, soups, oats, and soups through the addition of water. This products are nutritionally complete and macronutrient balanced, but sufficiently low in energy to induce weight loss. These products are provided to participants of the intervention arm at no cost. To allow some flexibility for participants, the active weight loss phase may continue up to 20 weeks if they chose too. If during the active weight loss phase the participant Body Mass index (BMI) falls below 23 kg/m2, they commence the second phase, which is weight loss maintenance. For the active weight loss phase, participants will return for review after the first week, and then in two weekly intervals thereafter for the active weight loss period. These appointments are expected to be of 20 minutes duration and comprise of checking the participants health and mood, answering any questions, body weight and blood pressure measurements, and providing more meal replacement products for the week(s) ahead. These meetings are between the participant, and the dietitian coordinating the study. Nine months of the weight loss maintenance phase commences once the participant leaves the active weight loss period. This second phase has a stepped food reintroduction period (flexible but up to two months duration) with supported for weight loss maintenance. During this reintroduction participants will move from 3-4 meal replacements each day to real food in health amounts along a time frame agreed upon by the participant and the Dietitian. During the stepped reintroduction of food participants will continue to see the Dietitian fortnightly. After food reintroduction, face to face meetings with the Dietitian are held monthly, although email and text or phone call support will continue when appropriate. These appointments are expected to be of 20 minutes duration and comprise of checking the participants health and mood, answering any questions, and taking body weight and blood pressure measurements. These meetings are between the participant, and the dietitian coordinating the study. During the nine months of supported weight loss, in the event of weight regain of 2-4kg, participants will be offered a 2-4 week period of partial meal replacement. This may be one or two meals each day from meal replacements and the remaining meals from food, depending on the goals and desires of the participant. In the event of weight regain over 4kg, participants will be offered a 2-4 week period of total diet replacement. The total intervention period of the study is 12 months. Adherence with the intervention will be assessed with 24 hour recalls (baseline, at three months, at 12 months) as will as session attendance checklists.