TECNOB Study: Ad Interim Results of a Randomized Controlled Trial of a Multidisciplinary Telecare Intervention for Obese Patients with Type-2 Diabetes

Study Sample

At present, 72 adult obese patients with a mean age of 53,3 ± 8,4 years, a mean weight of 120,25 ± 20,8 kg and type-2 diabetes mellitus have been recruited by research assistants at admission to a 1-month inpatient program for weight loss and medical care. Potential participants have been identified from notice given by physicians after they established a type-2 diabetes mellitus diagnosis. Further inclusion criteria were age between 18 and 65 years old, a body mass index (BMI) ≥ 30, basic knowledge of informatics and home access to a computer with Internet service. Moreover, patients had to be free of severe psychiatric disturbances diagnosed by DSM-fourth revised criteria and concurrent medical conditions not related to obesity. Eligible candidates were scheduled for a 1-hour interview with a clinical psychologist during which their psychosocial status was assessed, weight and dieting histories were reviewed, study details were described and informed consent was obtained.

At present, only 34 patients have completed the 3-month follow-up and have been considered for this first ad interim analysis. 21 patients out of them have come through the 6-month follow-up and 12 have achieved the end of program (12-month follow-up). 23 patients out of 72 have been lost at 3-month follow-up because of many reasons such as surgery, house transfer, repeated loss of mailed questionnaires, critical life-events, motivation loss, etc.

Study Design

A detailed description of the study protocol is available elsewhere [27]. Briefly, eligible patients who accepted participation were randomly assigned according to simple randomization procedures (computerized random numbers) to the TECNOB program or to a control condition. Participants were seen at baseline and at discharge from hospital for objective measurement of weight and questionnaires administration. Follow-up assessments at 3, 6 and 12 months were self-reported. All participants attended 1-month inpatient program for weight loss and medical care. Before discharge, participants allocated to the TECNOB group were instructed to use a weight-loss web-site, a dietary software installed into their cellular phones, a web-based videoconference tool and an electronic armband measuring daily steps and energy expenditure. To protect confidentiality, the web-site was password protected and participants were given a login identification code. Patients assigned to control group did not receive any instructions and were discharged as all the other inpatients not included in the study.

The research protocol was approved by the institutional review board at Istituto Auxologico Italiano, Italy.

Program Description

The TECNOB (TEChnology for OBesity) program is a comprehensive two-phase stepped down intervention enhanced by telecare for the long-term treatment of obese people with type 2 diabetes seeking treatment for weight loss [28]. The core aspects of TECNOB are the inpatient intensive treatment and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile phones.

The TECNOB clinical program has a total duration of 13 months and consists of two stepped down phases: inpatient (1 month) and outpatient (the following 12 months). During the inpatient phase, participants attend an intensive four week and medically-managed program for weight reduction and rehabilitation. All patients are placed on a hypocaloric nutritionally balanced diet tailored to the individual after consultation with a dietitian (energy intake around 80% of the basal energy expenditure estimated according to the Harris-Benedict equation and a macronutrient composition of 16% proteins, 25% fat and 59% carbohydrates). Furthermore, they receive nutritional counseling provided by a dietitian, brief psychological counseling provided by a clinical psychologist and have physical activity training provided by a physiotherapist.

Nutritional rehabilitation program aims to improve and promote change in eating habits and consists of both individual sessions (dietary assessment, evaluation of nutrient intake and adequacy, nutritional status, anthropometric, eating patterns, history of overweight, readiness to adopt change) and group sessions (45 minutes each twice a week) including: information on obesity and related health risks, setting of realistic goals for weight loss, healthy eating in general, general nutrition and core food groups, weight management and behavior change strategies for preventing relapse).

Psychological counseling is provided once a week both individually and in group setting. Individual sessions, lasting 45 minutes each, are mainly based on the cognitive-behavioral approach described by Cooper and Fairburn [29] and emphasize the techniques of self-monitoring, goal setting, time management, prompting and cueing, problem solving, cognitive restructuring, stress management and relapse prevention. Group sessions (small groups of 5/6 persons), lasting 1 hour each, focus on issues such as motivation to change, assertiveness, self-esteem, self-efficacy and coping.

Physical activity takes place once a day except for week-end and consists of group programs (20 individuals) based on postural gymnastics, aerobic activity and walks in the open. Patients with specific orthopedic complications carry out individual activities planned by physiotherapists and articulated in programs of physical therapy, assisted passive and active mobilization and isokinetic exercise.

Low to moderate weight losses are expected at the end of the inpatient phase, but notably weight loss is not the primary goal of the inpatient program and each patient is made clear about this point at the very beginning of the treatment. Developing a sense of autonomy and competence are the primary purposes of the inpatient interventions. Patients are afforded the skills and tools for change and are supported in assigning positive values to healthy behaviors and also in aligning them with personal values and lifestyle patterns.

In the last week of hospitalization, just before discharge from the hospital, participants allocated to the TECNOB program are instructed for the out-patient phase. Firstly, they receive a multisensory armband (SenseWear® Pro2 Armband), an electronic tool that enables automated monitoring of total energy expenditure (calories burned), active energy expenditure, physical activity duration and levels (METs). Patients are instructed to wear this device on the back of the upper arm and to record data for 36 hours every two weeks in a free-living context. The Armband holds up to 12 days of continuous data which the outpatients are instructed to download into their personal computer and to transmit online to a web-site specifically designed for data storing. Outpatients are also told that they can review their progress using the InnerView® Software which analyzes and organizes data into graphs and reports. Secondly, participants are instructed to use the TECNOB web-platform, an interactive web-site developed by TELBIOS S.P.A. (http://www.telbios.it). The TECNOB web-platform supports several functions and delivers many utilities, such as questionnaires, an animated food record diary, an agenda and a videoconference virtual room. In the “questionnaires” section, patients submit data concerning weight and glycated hemoglobin. In the “food record diary” participants submit actual food intake day by day through the selection of food images from a comprehensive visual database provided by METEDA S.P.A. (http://www.meteda.it). The same procedure is also possible through a software called METADIETA (Meteda s.p.a.) previously installed on the outpatients’ mobile phones before discharge. Through the mobile phones outpatients maintain the contact with the dietitian who regularly sends them SMS containing syntax codes that METADIETA, the software previously installed into the outpatients’ mobile phones, uses in order to visually display the food choices (frequency and portions) outpatients have to adhere according to dietary prescriptions. By this way, outpatients can keep a food record diary allowing comparisons between current eating and the recommended hypocaloric diet along the whole duration of the program. The “agenda” allows the patients to remember the videoconference appointments with the clinicians and the days when to fill in the questionnaires. Moreover, the patients can use the “memo” space to note down any important event occurred to him/her in the previous week/month. Indeed, some research indicates that changes in behavior (eating and exercise) often follow discrete moments [30]. Life events can lead to weight loss but also to weight gain and qualitative research shows that it is not the event per se that results in behavior change but the ways in which this event is appraised and interpreted by the individual [31]. The clinical psychologist has thus the opportunity to discuss with the outpatients about the significant events reported in the “memo” space during the videoconference sessions and cognitively reconstruct dysfunctional appraisals in functional ways. Finally, outpatients are instructed to use the videoconference tool. Thanks to this medium, they receive nutritional and cognitive-behavioral tele-counseling with the dietitian and the clinical psychologist who attended the patients inside the hospital. In particular, just after discharge, participants have 6 videoconference contacts with both clinicians along 3 months. From the 3rd to the 6th month sessions are scheduled every 30 days and then even more spaced up to an interval of 60 days. During tele-sessions, clinicians (psychologist and dietitian) test the outpatients’ progress, their mood, the maintenance of the “good alimentary and physical activity habits”, the loss/increase of weight and ask about critical moments, especially those ones reported on the “memo” web-space. In particular, tele-sessions with the clinical psychologist aim to consolidate strategies and abilities acquired during the in-patient phase, to improve self-esteem and self-efficacy, to support motivation, to prevent relapse and to provide problem-solving and crisis counseling. On the other hand, dietitian assesses adherence and compliance to dietary therapy with a special focus on normal eating behavior, sufficient fluid intake, hunger and fullness regulation, appropriate eating/etiquette (pace and timing of meals), slow rate of eating, and addresses critical points such as plateau in weight loss or lack of readiness to improve dietary habits.

In addition to videoconference, outpatients can further contact clinicians by e-mail. Indeed, each patient is given the possibility to join his clinician beyond the established video-conference contacts in case of urgency or emergency. According to the e-message’s content, clinicians choose the most appropriate format for delivering feedback among e-mail or telephone. In order to avoid excessive dependence and to contain costs, a maximum number of 1 not scheduled contact a week is established a priori.

Great relevance is given to the clinicians-patient relationship as an important medium and vehicle of change [32]. After discharge, out-patients begin to experience the autonomy and competence to change they develop during the in-patient phase and inevitably face resistances and barriers. Thanks to videoconferences, outpatients are supported by the clinicians who attended them during the inpatient phase in exploring resistances and barriers they experience and in finding functional pathways to cope. Furthermore, out-patients are helped to experience mastery in terms of the health behavior change that needs to be engaged.

Measurements

Primary outcome measure of the randomized trial is weight change in kilograms. Secondary outcome measures are energy expenditure, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habits formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. However, in this paper only weight and disordered eating-related behaviors and cognitions (EDI-2) data were analyzed and reported. Weight were assessed with the participant in lightweight clothing with shoes removed on a balance beam scale. The EDI-2 is a widely used, standardized, self-report measure of psychological symptoms commonly associated with anorexia nervosa, bulimia nervosa and other eating disorders. The EDI-2 does not yield a specific diagnosis of eating disorder. It is aimed at the measurement of psychological traits or symptom clusters presumed to have relevance to understanding and treatment of eating disorders. The EDI-2 consists of 11 subscales derived from 91 items. Three of the subscales were designed to assess attitudes and behaviors concerning eating, weight and shape (Drive for Thinness, Bulimia, Body Dissatisfaction) and the remaining eight ones tapped more general constructs or psychological traits clinically relevant to eating disorders (Ineffectiveness, Perfection, Interpersonal Distrust, Interoceptive Awareness, Maturity Fears, Asceticism, Impulse Regulation and Social Insecurity) [33, 34].

Follow-up EDI-2 data were self-reported by mailed questionnaires.

Statistical Analysis

Between-group differences in weight and glycated hemoglobin were examined at all time-points using the Mann-Whitney nonparametric test due to small sample and violation of parametric assumptions. A completers analysis was performed for any time-points (n=34 at 3 months, n=21 at 6 months and n=13 at 12 months). Changes over time were examined using the Wilcoxon test. Chi-square test was used for categorical variables.

All analyses were performed using the Statistical Package for Windows version 11 for the Social Sciences (SPSS, Chicago).

Baseline Characteristics

At baseline, there were no significant differences between groups in age, weight and percentage of females. However, statistically significant differences were found in some EDI-2 scales: Drive for Thinness (p=0,038), Ineffectiveness (p=0,049), Interoceptive awareness (p=0,003), Impulse regulation (p=0,045) and Social Insecurity (p=0,001) (see Table 1).

Weight Change

There were no significant differences between groups in weight at discharge and at 3-month follow-up. No significant difference was found even in weigh change and percentage of weight loss from baseline to discharge and to 3-month follow-up (Table 2 and Table 3). At 6 and 12 months, completers analysis of weight data did not show any significant difference between groups (Table 2 and Table 3). Moreover, no significant association between groups and number of patients who lost 5% or more of initial body weight was found at any time-point.

Given the lack of any significant between-group difference, patients were pooled in one group and weight change over time was examined by Wilcoxon nonparametric test. Within-group analyses revealed significant reductions of initial weight at discharge (-5,9 kg, p<0,000), at 3 months (-8,2 kg, p<0,000) and at 6 months (-7,6 kg, p=0,002). Reduction of baseline weight at 12 months was not statistically significant (-6,9 kg, p=0,136).

Eating-Related Behaviors and Cognitions (EDI-2)

Apart from the variables whose baseline median scores were shown to be statistically different between groups, a significant difference was found in Interpersonal distrust at 12 months (p=0,02). Patients in the control group had a higher median score compared with the TECNOB group (7 vs. 2).