Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes

Chiara Rafanelli

Status: Completed

Conditions: Overweight and Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Small change intervention; Other: Treatment as usual; Behavioral: Well-being intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03609463

PWLPWB-CVD

Details and patient eligibility

About

This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1) evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a behavioral intervention for overweight or obese patients with type 2 diabetes that takes stress and well-being into consideration, 3) evaluate appropriateness of research procedures and measures, 4) examine effect size estimates of key outcomes to provide essential data to inform a larger efficacy trial, 5) determine whether clinically significant improvements occurred in any key outcomes.

Full description

Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes clinics. Physicians will screen every patient attending to each clinic during the enrollment period for the presence of main eligibility criteria. Those patients who appear to be eligible will be introduced to the study and referred to a researcher for a more in-depth screening evaluation. Eligible patients who are interested in participating in the study will be asked to sign the informed consent. Consecutive patients will be randomly assigned in a 1:1 ratio to an experimental group or a control group. During the first month, participants in the experimental group will receive a well-being promoting intervention in adjunction to the treatment as usual (TAU), while those in the control group will be asked to follow the TAU. In the following 3 months participants in both groups will receive the small change intervention in adjunction to the the TAU. All in person sessions of the intervention will take place in an office of both the 2 diabetes clinics involved. Data about psychological and clinical variables will be collected for each participant through questionnaires and interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up. Participants' weight will be measured at each assessment point using a scale. Medical charts will be accessed to collect further data about physiological parameters, treatment received and medical history.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 25;
• Age ≥ 18;
• Diagnosis of type 2 diabetes;
• Fluent English or Italian.

Exclusion criteria

• Inability to provide informed consent to participate in the study for any reason, including cognitive impairment and psychiatric illness;
• Presence of any medical condition that would make participation in the study difficult and/or unsafe;
• Presence of any medical condition associated with unintentional weight loss or gain;
• Presence of untreated, severe and/or recently diagnosed (≤ 6 months) mental illness and/or presence of a severe personality disorder;
• History of eating disorders and/or substance abuse;
• Use of drugs for weight loss;
• Participation in another weight loss program or in any other trial;
• Participation in an individual or group psychological intervention;
• Weight loss surgery within the year;
• Pregnant or are planning to become pregnant within the year
• Inability to control meal contents (e.g. institutionalized patients).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Well-being and small change

Experimental group

Description:

Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.

Treatment:

Other: Treatment as usual

Behavioral: Well-being intervention

Behavioral: Small change intervention

Small change

Active Comparator group

Description:

Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.

Treatment:

Other: Treatment as usual

Behavioral: Small change intervention