Obesity Management

Practices randomised to control will continue to deliver usual diabetes and obesity management as per current clinical guidelines. Detailed information on usual care pathways will be recorded in each area. Participants recruited in these practices will be followed up for 2 years and seen on 3 occasions by the study research dietitians, for study outcome data collection (Additional file 1: Table 1).
Practices randomised to intervention will continue usual guideline-based care and also deliver Counterweight Plus, which includes a Total Diet Replacement (TDR) phase followed by structured food reintroduction (FR) and a structured support programme for long term weight loss maintenance. The intervention will be delivered to each participant individually, at their general practice, by either a practice nurse or local dietitian, depending on practice preference and availability of dietetic support. Participants will attend for 35 appointments over the 2-year intervention period (Additional file 1: Table 1).
Training (8 h) for the practice nurses/dietitians in delivery of Counterweight Plus and study protocol will be provided by the study research dietitians who are trained in the package developed for, and improved following, the Counterweight feasibility study in primary care [21 (link)]. A detailed description of the practical dietetic input will be published separately.

Aim2Be, which will be evaluated in this RCT, was built on the foundational knowledge learned in the first generation of the program called LiGHT (Living Green Healthy and Thrifty) and the second generation of the program, called Aim2Be version 1 (v1). LiGHT was an 11-module online program that integrated lifestyle behavior modification principles with environmental and financial concerns to address childhood obesity among 10- to 17-year-old children and their families [32 (link)]. Modest and nonsignificant improvements in readiness to change were initially observed for both the child and parents, likely due to ceiling effects on the measure and small sample size (N = 17 child-parent dyads). However, the qualitative feedback (N = 10 child-parent dyads) suggested that the LiGHT approach held promise. Specifically, both children and parents indicated that they related strongly to the foundational approach of the LiGHT intervention, meaning they liked having behaviors linked with health, environmental, and financial concerns. The evaluation also uncovered key areas that needed further improvement, including making the program more visually appealing, adding more interactivity, and creating a sense of community for the users.
The second generation of the intervention transitioned from a web-based intervention to a mobile app (iOs and Android) and was renamed Aim2Be. For those who do not have a smartphone, Aim2Be has remained accessible as a web-based platform via the internet. Aim2Be became a gamified app that supports children and their families to initiate sustainable behaviors in four primary areas: healthy eating, active living, reducing screen time, and healthy sleeping habits. It retained its focus on linking behaviors with health and living green, as well as adding emphasis on healthy body image and strong self-esteem. While Aim2Be retained some core elements from the LiGHT program, it 1) became strongly grounded in theories of behavior change (i.e., being family-based, supporting the development of self-regulatory skills at both the individual and familial levels, and enhancing self-efficacy through graded tasks) [10 (link), 11 (link), 19 (link), 33 ]; 2) integrated principles of maintenance of health behaviors and as such it included self-regulatory processes that support intrinsic motivation [34 (link)–38 (link)]; 3) integrated gamification practices, which are designed to maximize both enjoyment and motivation [39 (link)]; 4) recognized the importance of body image and self-confidence in lifestyle management; 5) used the mHealth context to support self-regulatory processes [40 (link)]; 6) aligned with best clinical practices and guidelines in three areas (including a) the treatment of childhood obesity in Canada as it aligns with the curriculum of Canadian Weight Management programs (e.g., being family based, multi-behavioral, and focused on supporting skill development at the individual and familial levels); b) clinical guidelines for the management of childhood obesity as it integrates the central elements that need to be incorporated in these interventions (e.g., family focused, focused on improving lifestyle behaviors, skill based support) [41 (link)]; and c) Canadian health recommendations including the Canadian 24 Hour Movement Guidelines [42 (link)] and Canada’s Food Guide [43 ]); and 7) was designed specifically with and for children and their families (see details below).
Aim2Be was iteratively and incrementally developed. The first version of Aim2Be (v1) was field tested for 4.5 months among 301 teens between 14- and 17-years old and 315 parents. The quantitative evaluation revealed that teens who were moderately and/or highly engaged in the app (> 30 min of app usage) as compared to those with low engagement (≤ 30 min of app usage) significantly increased their motivation and self-efficacy to improve their dietary habits (i.e., limit sugar-sweetened beverages and increase intake of fruits and vegetables) and sedentary behaviors (i.e., limit screen time). At 4.5 months, children significantly increased their previous day’s intake of fruits and vegetables, decreased their consumption of 100% fruit juice, and reduced their screen time. In addition, parents who were more engaged with Aim2Be v1 reported significant improvements in the children’s dietary behaviors (i.e., increased intake of fruits and vegetables and decreased intake of sugar-sweetened beverages). Additionally, multiple rounds of qualitative evaluations were conducted among 36 teens/preteens and 24 parents. The qualitative evaluations included both focus groups and 2-week prototype testing, followed by semi-structured interviews. The results of these evaluations led to numerous improvements in Aim2Be including clarifying the overall purpose of Aim2Be, supplementing the tracking and check-in sections, adding more engaging features, and syncing the app with physical activity monitoring (i.e., Fitbit).
The conceptual framework of Aim2Be is shown in Fig. 2. At its core, the behavior change techniques (BCT) incorporated in Aim2Be are rooted in 1) Social Cognitive Theory (SCT) [44 (link)]; 2) the Player Experience and Need Satisfaction (PENS) model, which is an extension of the Self Determination Theory model for the gamified context and incorporates enjoyment to support intrinsic motivation and the basic psychological needs that promote intrinsic motivation (autonomy, relatedness, and competence/self-efficacy) [39 (link), 45 (link)]; and 3) the ACUDO framework [46 ]. The ACUDO framework, is a best practice framework developed by Ayogo Health Inc. [46 ] to promote engagement and enjoyment by: a) supporting Agency, b) incorporating Challenges, c) infusing Uncertainty, d) supporting self-Discovery and exploration, and e) adding fun Outcomes such as rewards. Specifically, Aim2Be includes strategies that target 1) gamified mediators of behavior change to ensure the experience is both enjoyable and engaging; 2) behavioral mediators that aim to activate self-regulatory skills and support the development of intrinsic motivation and increase self-efficacy as a way to support behavior change and ultimately support healthy body weights; and 3) environmental mediators because it is recognized that behavior change needs to be physically and emotionally supported in the familial environment and that social support from both peers and/or coach is also important to changing health behaviors (see Fig. 2).
Fig. 2

Conceptual framework of Aim2Be

The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) pilot study aims to test whether it is feasible and acceptable to deliver a theory-based behaviour change intervention to support midwives in overcoming barriers to practice and to facilitate the implementation of weight management guidelines. The specific pilot study objectives are to:

Pilot the intervention delivery, data collection and analysis methods to assess feasibility and acceptability thereof

Explore the intervention’s active ingredients (in success or failure) through process evaluation

Collect baseline and outcome data required to inform sample size estimations and scope data collection procedures for economic evaluation within the definitive trial

The baseline questionnaires were used to evaluate some potential confounding variables: sociodemographic factors (age, sex, ethnic background and household income), socioeconomic status (Townsend Deprivation Index), lifestyle habits (smoking status, alcohol consumption, tea intake, processed meat intake obesity, dietary intake (fruits and vegetables). Furthermore, medication use (blood pressure drugs and cholesterol-lowering drugs use), vitamin supplements (vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, multivitamins, or folic acid), minerals supplements (calcium, iron, zinc or selenium) and comorbidities (hypertension, diabetes, high cholesterol and long-term illness) were evaluated. The Townsend Deprivation Index was provided in the UK Biobank. The information for medical history (hypertension, diabetes, high cholesterol and long-term illness) was obtained through self-report at baseline. The body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared. In this study, obesity was considered as BMI ≥ 30, which consists with the European guidelines for obesity management in adults [19 (link)]. Details of these evaluations could be obtained from UK Biobank (www.ukbiobank.ac.uk).

In 2014–2018 twenty-five Caucasian men and women patients with a BMI of 30–35 kg/m2 and diagnosed type 2 diabetes (duration <10 years) were qualified for the study. They underwent surgery and were subjected to postoperative follow-up 12 months after the operation. No control group was formed due to the nature of the study and the parameters evaluated. To exclude latent autoimmune diabetes of adults (LADA) type diabetes an anti-glutamic acid decarboxylase (anti-GAD) antibody test was performed as well as a C-peptide level determination on fasting (>1 ng/ml) and after glucagon loading to define pancreatic reserves of insulin.
Polish recommendations in bariatric and metabolic surgery have been developed based on the guidelines American Diabetes Federation (ADA), European Guidelines for Obesity Management in Adults, American Association of Clinical Endocrinologist, The Obesity Society, American Society for Metabolic and Bariatric Surgery (AACE, TOS, ASMBS), International Diabetes Federation (IDF) and European Association for Endoscopic Surgery (EAES) guidelines. [13 ]. Qualification for surgical bariatric/metabolic treatment is one of the key factors influencing its outcomes. Before offering the patient a surgical treatment, we analyze the previous history of attempts to reduce weight and prequalify the patient for surgery. The final qualification of the patient for surgery is multidisciplinary: it is a decision of a team consisting of specialists experienced in obesity treatment, namely, a surgeon, internist, anaesthesiologist, psychologist or psychiatrist , dietician, physiotherapist, and, if necessary, a cardiologist, pulmonologist, gastroenterologist and neurologist. Recommendations also define the optimal time of patient preparation for surgery, it should not be shorter than 3 months or longer than 6–12 months.

The reporting of this study conforms to the STROBE guidelines.¹¹Retrospective cohort study of anonymized secondary data, whose follow‐up begins from the indication of the surgical procedure to 1 year postoperatively. A population of patients undergoing MBS was taken from a highly complex institution specialized in bariatric surgery in the city of Bucaramanga and its metropolitan area, Colombia, between January 2015 and December 2019.
Inclusion criteria: Patients between 18 and 80 years old, BMI > 30 kg/m², strict follow‐up at 1 year of the clinical variables already exposed. Exclusion criteria: Patient with previous bariatric surgeries. In addition, the type of procedure to be performed was taken from the management guidelines of the Colombian Association of Obesity and Bariatric Surgery.