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Cited by 19Obesity, Physical Activity, DietObesity and Health PracticesPharmacology and Obesity Treatment

The SHED-IT Weight Loss Maintenance trial protocol: A randomised controlled trial of a weight loss maintenance program for overweight and obese men

Open access
Young, Myles D., Collins, Clare E., Callister, Robin, Plotnikoff, Ronald C., Doran, Christopher M., Morgan, Philip J.·2014·Contemporary Clinical Trials
DOI 10.1016/j.cct.2013.11.004
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Abstract

Unlabelled Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study will test the effectiveness and cost-effectiveness of a male-only weight loss maintenance intervention. In Phase I (3 months) 209 men received the SHED-IT Weight Loss Program. In Phase II (12 months) 92 men who lost 4 kg or more were randomised to either (i) a maintenance group who received the 6-month, gender-tailored SHED-IT Weight Loss Maintenance Program, which included no face-to-face contact (n = 47), or (ii) a self-help control group (n = 45). Randomisation was stratified by weight loss (4 kg-7.4 kg, ≥7.5 kg) and BMI (<30 kg/m(2), ≥30 kg/m(2)). Assessments occurred at 'study entry' (start of Phase I), 'baseline' (start of Phase II), '6 months' (post-test) and will occur at '12 months' (follow-up; primary endpoint). The primary outcome is weight change in Phase II (i.e. from 'baseline' at 12 months after randomization). Secondary outcomes include waist circumference (umbilicus and narrowest), blood pressure, body composition, objectively measured physical activity, sedentary time, portion size, dietary intake, quality of life, depressive symptoms, and behavioural cognitions. Costing data will be collected for cost-effectiveness analysis. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (maintenance vs. control), time (baseline, 6-month and 12-month) and the treatment-by-time interaction. This will be the first study to evaluate a male-only, gender-targeted weight loss maintenance program. Results will provide evidence regarding feasible and theoretically-driven obesity treatments for men with potential for long-term impact and widespread dissemination.Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12612000749808).

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  • BCTTv1 has been used to code interventions across a variety of behavioural domains, including physical activity and dietary behaviours, oral hygiene, hazardous and harmful drinking, sexual health, blood pressure control/management, antibiotic-prescribing and diabetes preventative behaviours.

    “BCTTv1 has been used to code interventions across a variety of behavioural domains, including physical activity and dietary behaviours [31, 32], oral hygiene behaviours [33], hazardous and harmful drinking [34], sexual health behaviours [35–37], blood pressure control/management behaviours [38], antibiotic-prescribing [39, 40] and diabetes preventative behaviours [41].”

    From From Theory-Inspired to Theory-Based Interventions: A Protocol for Developing and Testing a Methodology for Linking Behaviour Change Techniques to Theoretical Mechanisms of Action (2018) · cites this paper as [31]

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Authors
Young, M. D., Collins, C. E., Callister, R., Plotnikoff, R. C., Doran, C. M., & Morgan, P. J.
Affiliations
  • University of Newcastle Australia (AU)
  • Edith Cowan University (AU)
Corresponding author
Morgan, Philip J.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2014-01
Volume
37
Issue
1
Pages
84-97
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2013.11.004
OpenAlex
W2036172551
Cited by
19
References
89
Citations by year
2022: 1 · 2021: 2 · 2020: 3 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 3 · 2015: 4 · 2014: 1
FWCI
2.72
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Contemporary Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
  • Acquire (CQUniversity) (submittedVersion)
  • Research Online (Edith Cowan University) (submittedVersion)
  • Figshare (submittedVersion, cc-by)
  • Figshare (submittedVersion)
  • NOVA (University of Newcastle Australia) (submittedVersion, cc-by-nc-nd)
Funders
Cancer Council Victoria
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
  • Health Sciences › Health Professions › Pharmacy › Obesity and Health Practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
weight loss maintenance, obesity, overweight men, gender-tailored interventions, long-term weight loss, cost-effectiveness, self-help, physical activity, sedentary time, dietary intake, depressive symptoms, quality of life, body composition, waist circumference, blood pressure
MeSH terms
Adolescent, Adult, Aged, Cost-Benefit Analysis, Humans, Longitudinal Studies, Male, Middle Aged, Obesity, Body Mass Index, Single-Blind Method, Treatment Outcome, Overweight, Young Adult, Weight Reduction Programs

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