“Ho-DiRECT”- A food-based educational and home economic intervention for type-II diabetes remission

Type 2 diabetes (T2D) has been shown to be reversible, remission to a non-diabetic state without need for medication, by substantial weight loss in UK Diabetes Remission Clinical Trial (DiRECT). This project aims to establish, evaluate, and generate pilot data to improve a novel low-cost, community-owned, intervention for weight loss, using traditional Nepalese meal patterns, based on the principles of the DiRECT. It is pilot research to examine the feasibility of a dietary intervention to reduce weight loss and achieve diabetes remission among 60 T2D patients of Metro Kathmandu Hospital. The intervention, a culturally adapted version of that used successfully in the UK DiRECT study, involves an initial 'Total Diet Replacement' phase, consuming three nutritionally complete meals of ~280kcal, total ~850kcal/day, to achieve >10kg (ideally >15kg) weight loss over 8-12 weeks, and then local dietary weight maintenance advice. The study outcome is remission of diabetes (HbA1c 15kg for Europeans). The study involves the following steps:

  1. Participant recruitment:

The participant recruitment will be conducted within care of diabetes specialists of respective hospitals and nutritionists/ dieticians. Ambulatory patients (satisfying the inclusion criteria) visiting the hospitals will be requested to participate in the program. The research assistant (RA) will inform the participants about the project details, its objectives, benefits, and risks. The participants who will be willing to participate in the study will be asked to sign an informed consent before they are enrolled in the study. Then they will be given a tracking booklet where they have to fill the food, they eat according to the time regularly for a week. 

  1. Intervention

First, RAs will receive training on dietary intervention, data collection and ethical issues. Participants will be educated about T2D and its multimorbid complications, home-economics education on food and nutrition, and offered the dietary intervention program. RA and nutritionists will contact the participants on a 2- weekly basis, up-to week – 10 and then 4-weekly. Diet intake of the participants will be filled in the Keeping Track Booklet.  Anthropometric measurements and biochemistry will be conducted routinely. The dietary intervention program consists of:

    i) Total Diet Replacement (TDR) Phase which will last for the first 8-10 weeks and in this phase also, participants will be asked to follow recommended TDR diet and fill up the tracking booklet. As in the DiRECT and DIADEM-1 trials, glucose-lowering medications will be withdrawn at the start (with a reintroduction protocol according to blood glucose). Then, they will be asked to consume three nutritionally complete meals of ~280kcal, total ~850kcal/day, to achieve >10kg (ideally >15kg) weight loss over 8-10 weeks by the team using low-cost traditional foods, similar to the Scottish ‘No Doubts Diet’ based on porridge and lentil soups. TDR diets for participants have been prepared using Nepali traditional food items (Annex-I). Also, they will be given a booklet with checklists of the food components of TDR where they have to tick the food, they eat in a day regularly for 8 weeks. 

    ii) Weight Maintenance phase

Diet for the weight maintenance phase will be developed with the help of dieticians/ nutritionists. The participants will be advised to follow a local food-based diet to support weight stabilization and prevent weight regain. Weight-control support will continue irrespective of T2D remission, aiming to limit related multimorbid conditions. Those not achieving remissions will be referred to medical services.

 3. Follow-Up

The participants recruited in the study will be followed up for 2 years and seen on 3 occasions i.e.,12 weeks, 26 weeks, and 52 weeks by the study research team, for study outcome data collection. Body weight and HbA1c will be measured at baseline, 12 weeks, 26 weeks, and 52 weeks, together with blood pressure, microalbuminuria, liver-function tests and ultrasound liver fat. A questionnaire will be designed and used to record qualitative information about the experiences of the participants, to improve the intervention

Objective

To establish feasibility, and refine protocol and methods, and establish pilot data for a power estimation to be able to mount a definitive randomized trial of a novel low-cost, dietary program for weight loss, prevention or remission of type 2 diabetes, and reduction of cardiometabolic risk factors.

Specific objectives:

    1. To evaluate change in HbA1c and weight loss due to dietary intervention
    2. Establish the accessibility, affordability, and acceptability of the Nepalese diet interventions for (i) inducing and (ii) maintaining weight loss.
    3. Evaluate the potential barriers and facilitators to diet change among the participants, and ways to overcome them.

Outcome

Type-II diabetes is a potentially reversible disease, with a dietary intervention replacing conventional drug treatments, is rising in the UK and world-wide, because of the DiRECT trial The expected outcomes are decrease in weight of the participant with the given diet with decrease in HbA1c without medication. This will cause the remission of diabetes.

Team Members

Co-Principal Investigators: Prof. Michael Lean, Dr. Sujata Sapkota,

Co-Investigators: Rashmi Maharjan, Dr. Abha Shrestha, Dr. Jyoti Bhattrai, Ruby Shrestha, Deepa laxmi Makaju, Dr. Charoula Nikolaou, Dr. Binaya Bhattrai

Project Coordinators: Prasanna Rai

Supported by: All SAINT EDUCATIONAL TRUST (ASET)