Manchester Intermittent versus Daily Diet App Study (MIDDAS): A pilot randomized controlled trial in patients with type 2 diabetes.

AIMS: To test the feasibility and potential efficacy of remotely supported intermittent low-energy diets (ILEDs) and continuous low-energy diets (CLEDs) in people with type 2 diabetes (T2D) and the feasibility of a randomized controlled trial comparing the two approaches. MATERIALS AND METHODS: Seventy-nine adults with overweight/obesity and T2D (≤8 years duration) were randomized 1:1 to CLED (8 weeks/56 days of daily Optifast 820 kcal (3430 kJ) diet) or isoenergetic ILED (2 days of Optifast and 5 days of a Mediterranean diet/week for 28 weeks). Weight maintenance/continued weight loss was undertaken for the remainder of the 52 weeks. Both groups received frequent telephone or the Oviva app support. Feasibility outcomes included study uptake, retention, app usage, dietary adherence, weight loss and change in glycated haemoglobin (HbA1c) at 52 weeks. RESULTS: We enrolled 39 ILED and 40 CLED participants and 27 (69%) ILED and 30 CLED (75%) attended the 52-week follow-up. Eighty-nine per cent (70 of 79) started using the app and 86% (44 of 51) still used the app at 52 weeks. Intention-to-treat analysis at 52 weeks showed percentage weight loss was mean (95% confidence interval) -5.4% (-7.6, -3.1%) for ILED and -6.0% (-7.9, -4.0%) for CLED. HbA1c <48 mmol/mol was achieved in 42% of both groups. Mean (95% confidence interval) changes in the T2D medication effect score were 0.0008 (-0.3, 0.3) for ILED and -0.5 (-0.8, -0.3) for CLED. CONCLUSION: The study shows the feasibility and potential efficacy of remotely delivered ILED and CLED programmes for weight loss and HbA1c reduction, and the feasibility of a randomized controlled trial comparing the two approaches.

Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Intensive face-to-face weight loss programs using continuous low-energy diets (CLEDs) providing approximately 800 kcal per day (3347 kJ per day) can produce significant weight loss and remission from type 2 diabetes (T2D). Intermittent low-energy diets (ILEDs) and remotely delivered programs could be viable alternatives that may support patient choice and adherence. OBJECTIVE: This paper describes the protocol of a pilot randomized controlled trial to test the feasibility and potential efficacy of remotely supported isocaloric ILED and CLED programs among patients with overweight and obesity and T2D. METHODS: A total of 79 participants were recruited from primary care, two National Health Service hospital trusts, and a voluntary T2D research register in the United Kingdom. The participants were randomized to a remotely delivered ILED (n=39) or CLED (n=40). The active weight loss phase of CLED involved 8 weeks of Optifast 820 kcal/3430 kJ formula diet, followed by 4 weeks of food reintroduction. The active weight loss phase of ILED (n=39) comprised 2 days of Optifast 820 kcal/3430 kJ diet and 5 days of a portion-controlled Mediterranean diet for 28 weeks. Both groups were asked to complete 56 Optifast 820 kcal/3430 kJ days during their active weight loss phase with an equivalent energy deficit. The diets were isocaloric for the remainder of the 12 months. CLED participants were asked to follow a portion-controlled Mediterranean diet 7 days per week. ILED followed 1-2 days per week of a food-based 820 kcal/3430 kJ diet and a portion-controlled Mediterranean diet for 5-6 days per week. Participants received high-frequency (weekly, fortnightly, or monthly depending on the stage of the trial) multidisciplinary remote support from a dietitian, nurse, exercise specialist, and psychologist via telephone or the Oviva smartphone app. The primary outcomes of the study were uptake, weight loss, and changes in glycated hemoglobin at 12 months. An outcome assessment of trial retention was retrospectively added. Secondary outcomes included an assessment of adherence and adverse events. A qualitative evaluation was undertaken via interviews with participants and health care professionals who delivered the intervention. RESULTS: A total of 79 overweight or obese participants aged 18-75 years and diagnosed with T2D in the last 8 years were recruited to the Manchester Intermittent and Daily Diet Diabetes App Study (MIDDAS). Recruitment began in February 2018, and data collection was completed in February 2020. Data analysis began in June 2020, and the first results are expected to be submitted for publication in 2021. CONCLUSIONS: The outcomes of the MIDDAS study will inform the feasibility of remotely delivered ILED and CLED programs in clinical practice and the requirement for a larger-scale randomized controlled trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 15394285; http://www.isrctn.com/ISRCTN15394285. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21116.

The maternity experiences of indigenous women admitted to an acute care setting.

This is the report of stage two of a three-stage project. The aim of the project is to develop educational resources through information and experiences provided by Aboriginal and Torres Strait Islander women and health care professionals. The objectives were to optimise collaboration and participation by Indigenous and Torres Strait Islander women in sharing their maternity experiences about the birthing of their babies either in hospital, or out of hospital before arrival. The descriptive research of stage two explores issues that existed for twelve Indigenous women during and after their birthing experiences in an acute care setting. The results will inform patient and professional educational programs and policy in order to enhance the experiences for Indigenous women admitted to the acute care setting before or following birth. The results show broad variation in responses related to antenatal care, preparation for hospital and for birth, coming into town, accommodation, family support, experiences while in hospital, relationship with hospital staff and being away from home. Miscommunication and lack of cultural and spiritual understanding by health care professionals generally is a constant theme. The need for preparation of Indigenous women generally, prior to admission to an acute care setting, is confirmed.

Developing strategies to gather information about the maternity experiences of indigenous women in an acute care setting.

This project emerged from the concerns of health care professionals at a large acute care hospital in the Northern Territory of Australia. The aim of the project was to develop educational resources through information and experiences provided by Aboriginal and Torres Strait Islander women and health care professionals. The objectives are to optimise collaboration and participation by Indigenous and Torres Strait Islander women in sharing their maternity experiences about the birthing of their baby either in hospital, or out of hospital before arrival. Stage one of a three stage project is reported here. In stage one a modified Delphi method was used to interview ten purposefully chosen professional Indigenous women with insight into the research process and changing social arrangements. Stage two involved the development of an interview schedule and face-to-face interviews. Stage three includes the development of a questionnaire to be answered by health care professionals. Discussion of the background to the study, reviewed literature and issues identified from interviews with the professional Indigenous women regarding best methods and appropriate data collection processes is presented. Research described here explores issues of concern for Indigenous women from the Northern Territory around their child birthing experiences in an acute care setting.

Opinions of healthcare professionals regarding the maternity experiences of indigenous women in an acute care setting.

This is the report of stage three of a three stage project. The aims of the overall project were to seek advice from expert Indigenous women on how to gather information from birthing Indigenous women while in hospital. Information was gathered from Indigenous women who gave birth in hospital or were admitted after the birth of their baby. The opinions of healthcare professionals on the care of these women were investigated. This paper describes the opinions and concerns of healthcare professionals regarding identified cultural, social and economical issues for Indigenous women at a large acute care hospital in the Northern Territory, Australia. The opinions of healthcare professionals are vital if the needs and concerns of Indigenous women are to be considered within the hospital setting. Stages one and two of this project have been presented previously. Stage three, reported here, describes a survey of 18 non-Indigenous and one Indigenous healthcare professionals regarding their opinions of the maternity experiences of Indigenous women admitted to an acute care setting. The consultative process for designing the questionnaire and reflections on issues raised by Indigenous women during their interviews in the previous two stages is presented. The methodology of the survey, demographics and perceptions of healthcare professionals who participated in the project are examined and the similarities and differences between the issues raised by the healthcare professionals and the Indigenous women in stage two of the project are discussed. Suggestions made by the healthcare professionals regarding improving quality of care for Indigenous women when admitted to an acute healthcare setting are presented.