Lifestyle Strategies for Improving Diabetes Outcomes

NCT02210845 | Unknown DMC

• 1 other identifier: DOS-23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate whether a behavioral modification intervention in the form of either a 6-month supervised training program or a 6-month financial incentive weight loss program, results in improvement of diabetes outcome such as overall sugar control and lipid control.

Conditions

Diabetes

Keywords

Diabetes; Supervised Exercise; Weight loss

Outcome Measures

Primary Outcomes (1)

• Three months average blood glucose (A1c)

  We will assess the effect of supervised training and financially incentivized weight loss on three month average blood glucose in patients with diabetes.

  at 3 months and 6 months

Secondary Outcomes (3)

• apo B

  6 months

• systolic blood pressure (SBP)

  3 months and 6 months

• A1c

  3 months and 6 months

Other Outcomes (4)

• Composite: Psychosocial outcomes are depressive symptoms, Diabetes specific quality of life

  3 months and 6 months,

• waist circumference

  3 months and 6 months,

• weight

  3 months and 6 months,

Study Arms (3)

Financially incentivized weight loss

ACTIVE COMPARATOR

Participants can be assigned to the financially incentivized weight loss group in which they can receive 50 dollars at the end of the month if they achieve their monthly weight loss goal.

Behavioral: Financially incentivized weight Loss

Standard of Care

PLACEBO COMPARATOR

Participants can be assigned to standard of care where they receive no intervention.

Other: Standard Care at BCDiabetes

Supervised Exercise

ACTIVE COMPARATOR

Participants can be assigned to the supervised exercise arm which they will receive supervised professional training once a week.

Behavioral: Supervised exercise

Interventions

Supervised exercise BEHAVIORAL

Supervised exercise intervention is training with professional trainers once a week. It will include aerobic exercise tailored to the individual participant.

Supervised Exercise

Financially incentivized weight Loss BEHAVIORAL

Financially incentivized weight loss encourages participants to achieve a monthly goal weight reduction for a 50 dollars prize.

Financially incentivized weight loss

Standard Care at BCDiabetes OTHER

usual care dictated by GCP at BCDiabetes.ca

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Have been diagnosed with Type 2 diabetes by CDA guidelines.
• A1c \> 8.0 no more than 30 days prior to randomization and confirmed at the time of randomization.
• Overweight or obese as defined by BMI of \>25.

You may not qualify if:

• Have medical co-morbidities that limit their exercise capacity (terminal cancer, severe physical disability such as limb amputation, blindness, seizure disorder, strokes with residual deficits, arrhythmias that would limit physical activity).
• Alcohol or drug abuse that would interfere with exercise regimen.
• Cannot read or write English (with the assistance of an interpreter) or are unable to fill out logs and questionnaire.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
• Patients for whom an exercise program is deemed medically inadvisable.
• Patients already enrolled in a supervised training program.

Sponsors & Collaborators

• Tom Elliott: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

Related Publications (3)

• Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

  PMID: 19896746 BACKGROUND

• Klein S, Sheard NF, Pi-Sunyer X, Daly A, Wylie-Rosett J, Kulkarni K, Clark NG; American Diabetes Association; North American Association for the Study of Obesity; American Society for Clinical Nutrition. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies. A statement of the American Diabetes Association, the North American Association for the Study of Obesity, and the American Society for Clinical Nutrition. Am J Clin Nutr. 2004 Aug;80(2):257-63. doi: 10.1093/ajcn/80.2.257.

  PMID: 15277143 BACKGROUND

• Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003 Oct;22(5):331-9. doi: 10.1080/07315724.2003.10719316.

  PMID: 14559925 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom Elliott, MD

  BCDiabetes.Ca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandana Moosavi, MDCM

CONTACT

6043604704; mandana.moosavi@mail.mcgill.ca

Tom Elliott, MD

CONTACT

6046752491; telliott@bcdiabetes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 7, 2014
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)