Authors
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University of Canberra Reserach Institute for Sport and Exercise -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2017
INTERVENTION: This 8‐month randomised cross‐over trial is designed to determine if the addition of telephone and text message support to a community based obesity management program improves lifestyle intervention adherence and clinical outcomes when compared to standard care. The additional support will be grounded in behaviour change theory, with a range of behavioural treatment strategies targeted, including: goal setting, self‐monitoring, motivational interviewing, problem solving, relapse prevention, stimulus control, cognitive restructuring and self‐reinforcement. This study will be conducted within the ACT Health Obesity Management Service (OMS). Participants will be randomly assigned to receive four months of telephone and text message support (tech‐support) in addition to standard OMS care, or standard OMS care alone. After four months, the participants will cross over to the alternative sequence for four additional months. One group will therefore receive the tech‐support intervention first, followed by the standard care condition (TS‐SC), while the other group will receive the standard care condition first, followed by the tech‐support intervention (SC‐TS). Telephone calls will be provided monthly throughout the four‐month intervention period (maximum of four calls). A range of behavioural treatment strategies will be targeted within these calls, and participants will be guided to set two‐three S.M.A.R.T goals to work toward over the following month. Potential strategies to achieve these goals will be discussed, including problem solving and self‐monitoring. The information gathered within these telephone calls will be used to tailor and individualise the subsequent month of text messages. Three text messages will be sent each week, aimed to remind or prompt participants to strive toward their goals, as well as foster a sense of support and accountability. Wording of text messages will be tailored to individuals based on their chosen goals, identified barriers and strategies to overcome them, preparatory behaviours to achieve their goals and self‐monitoring strategies. The primary investigator (Accredited Practicing Dietitian and Accredited Exercise Physiologist) will conduct all telephone calls at a time mutually convenient to both parties. Telephone calls will be roughly 15‐20 minutes in duration. Text messages will be manually written every month following the participant’s telephone call and sent on an automated timer using a software program. A research assistant may be employed to assist with the intervention, pending the speed of rolling recruitment. If this does occur, fidelity checklists will be prepared for telephone calls, text messages and face‐to‐face assessment appointments. Checklists for each session will specify (a) prescribed/ scripted session content and (b) proscribed session content. All research assistants will be thoroughly orientated to the requirements. CONDITION: Obesity PRIMARY OUTCOME: Dietary adherence ‐ measured using changes in dietary habits via the Fat and Fibre Behaviour Questionnaire. This questionnaire assesses eating habits over the previous month. Eleven items relate to consumption of high fat or fibre foods, and the remaining nine items ask about behaviours related to cooking, eating or choice of foods. Physical activity adherence ‐ measured by change in total minutes of physical activity per week and/or change in total steps per week using accelerometers worn for seven consecutive days, accompanied by a seven‐day physical activity diary. SECONDARY OUTCOME: BMI ‐ measured using height and weight Eating self‐efficacy ‐ measured using the Weight Efficacy Lifestyle Questionnaire – Short Form (WEL‐SF), an eight item self‐report measure used to assess changes in weight management self‐efficacy, with high scores reflecting self‐confidence for controlling eating behaviour in particular situations. Exercise self‐efficacy ‐ measured using the Physical Activity Assessment Inventory (PAAI). The PAAI is a 13‐item scale that asks respondents to rate how confident they are that they can perform their usual physical activity in a variety of circumstances. Scores range from 0 – 1300, with higher scores indicating greater self‐efficacy for physical activity. Treatment self‐regulation, measured using the treatment self‐regulation for diet and exercise questionnaires. Waist circumference ‐ measured in the horizontal plane midway between the lowest rib and the iliac crest. Weight ‐ measured without shoes using a digital scale accurate to 0.1kg. INCLUSION CRITERIA: Inclusion criteria include: (a) BMI >40kg/m2; (b) >18 years of age; (c) access to a mobile phone, computer and internet connection; (d) sufficient technological literacy and English skills; (e) willing and able to receive three weekly texts and one monthly phone call over a period of six months; and (f) willing and able to attend follow‐up assessments over the next 12 months. Participants will be both male and female.
Epistemonikos ID: 10f25c8e7cae2012fd41e8bbe695b5a047ae0c98
First added on: Aug 23, 2024