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

March 11, 2021 updated by: Chiara Rafanelli

Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Cremona
      • Casalmaggiore, Cremona, Italy, 26041
        • Struttura Semplice di Endocrinologia e Metabolismo, Ospedale Oglio Po
    • Forlì-Cesena
      • Cesena, Forlì-Cesena, Italy, 47521
        • Servizio Endocrinologia e Diabetologia, Ospedale Bufalini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Well-being and small change
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.
Behavioral: Small change intervention
The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.
Behavioral: Well-being intervention
The well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting.
Other: Treatment as usual
The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.
Active Comparator: Small change
Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
Behavioral: Small change intervention
The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.
Other: Treatment as usual
The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility (Recruitment)
Time Frame: Baseline
Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).
Baseline
Feasibility (Retention)
Time Frame: Through study completion, intended to be 16 months
Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).
Through study completion, intended to be 16 months
Feasibility (Acceptability of Intervention)
Time Frame: Post-intervention, intended to be 4 months
Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.
Post-intervention, intended to be 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Psychological Distress
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Measured by the Symptoms Questionnaire (SQ), a 92-item self-rating scale with yes/no responses (or true/false for some questions to avoid double-negative statements) divided into four domains: anxiety, depression, somatic, and anger-hostility.

Each domain is further divided into two sub-scales: one sub-scale with 17 symptom questions and one sub-scale with 6 questions that are antonyms of some of the symptom questions in order to measure well-being.

A response of yes/true for a symptom question gives 1 point, and a response of no/false for a well-being question gives 1 point for a score ranging from 0-17 for each symptom sub-scale and 0-6 for each well-being sub-scale, where a higher score indicates greater distress. If the well-being score is calculated separately the raw score can be subtracted from 6 for a score ranging from 0-6, where a higher score indicates greater well-being.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Distress and Well-Being
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Measured by the Psychosocial Index (PSI), a 55-item self-rating scale divided into five domains:

Sociodemographic and clinical data: 12 questions including routine medical and demographic information. Stress: 17 yes/no questions with a score from 0-17. A higher score indicates greater stress. Well-being: 6 yes/no questions with a score from 0-6. A higher score indicates greater psychological well-being. Psychological distress: 15 four-point questions from 0-3, with a total score from 0-45. A higher score indicates greater psychological distress. 4 questions referring to sleep may be scored separately. Abnormal illness behavior: 3 four-point questions from 0-3, with a total score from 0-9. A higher score indicates more severe abnormal illness behavior. Quality of life: 1 four-point question, with a score from 0 to 4. A higher score indicates a higher quality of life. Psychological well-being and quality of life scores can be summed for a global well-being score from 0-10.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Well-Being
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured by the Psychological Well-Being scale (PWB), a 42-question self-rating scale for the assessment of 6 dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. Each of the 42 six-point response questions are given a score from 1-6, with questions phrased in the negative reversed (e.g. 1 to 6, 6 to 1). The total score in each dimension ranges from 7-42, and all the dimensions scores are summed to give a final total ranging from 42-252, with higher scores indicating greater psychological well-being.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
% Weight Change
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured in kg.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Prevalence of Psychosomatic Syndromes
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured by the Diagnostic Criteria for Psychosomatic Research - Revised (DCPR-R), which uses a semi-structured interview of yes/no questions (DCPR-R SSI) to assess for the presence of 14 different psychosomatic syndromes. The prevalence will be reported as a within-population mean for each of the 14 syndromes described by the DCPR-R.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Hemoglobin A1C
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Hemoglobin A1C levels will be obtained from patients' medical record.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Abdominal Circumference
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Abdominal circumference will be measured in centimeters with a tape ruler.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Physical Activity, Eating Habits, and Stress
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Measured by the GOSPEL questionnaire, a 32-item self-rating instrument for the assessment of physical activity levels, eating habits, and stress tailored to the dietary variation among Italian adults:

Seven 4-point items regarding physical activity with a total score from 0 (least active) to 20 (most active).

Ten 4-point items regarding diet based on frequency of consumption, with scores summed to obtain a Mediterranean diet score from 0 (worst) to 30 (best).

Three 4-point items on eating habits summed for a score ranging from 0 (worst habits) to 9 (best habits).

Diet and eating habits are summed to give a total diet score from 0 (worst) to 39 (best).

Seven 4-point items regarding stress management summed for a total score from 0 (optimal management) to 21 (inadequate management).

Four 4-point items on family risk behaviors with a score ranging from 0 (least risky) to 4 (most risky).

One 4-point item on family support scored from 0 (least support) to 3 (most support).
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Food-Related Behaviors
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured by the Dutch Eating Behavior Questionnaire (DEB-Q), a 33-item self-rating instrument for the assessment of restrained (10 items), emotional (13 items), and external (10 items) eating behavior. Each item ranges from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the particular eating behavior, and thus a greater propensity to behavior associated with increased BMI. The mean score from each of the three sub-scales is reported.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Motivation for Weight Loss
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured by the Goal Related Weight Questionnaire (GRWQ). The first section consists of 4 items and assesses the respondent's dream weight, happy weight, acceptable weight, and disappointed weight in kilograms. The respondent also writes the most important changes they hope to see following weight loss in one free-response question. The second section consists of 21 items asking the respondent to rate how they expect weight loss to impact various aspects of their psychosocial and health-related functioning, with each item scored from 1 (extremely negative) to 10 (extremely positive).
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Health-Related Quality of Life
Time Frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Measured by the 12-item Short Form Survey (SF-12), a 12-item self-rating scale for the assessment of physical and mental health comprising 8 domains: physical functioning, role-physical, bodily pain, general health, energy/fatigue, social functioning, role-emotional, mental health, and change in health. The weighted means of the 8 domains are calculated to develop two composite scores (Physical Health and Mental Health) ranging from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiara Rafanelli

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chiara Rafanelli, MD, PhD, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PWLPWB-CVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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