Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Photography of meals/snacks and group discussion
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Nutrition, Digital photography, Self-management
Eligibility Criteria
Inclusion Criteria: Must be a patient of the Joslin Diabetes Center Must have type 2 diabetes Must be between 30 and 60 years of age Must have a BMI equal to or greater than 30 Must agree to randomization Must provide written informed consent Exclusion Criteria: Unable to give written informed consent Unable to communicate in and read English A severe visual impairment Pregnancy Non-compliance or unlikely to return for the treatment
Sites / Locations
- Joslin Diabetes Center
Outcomes
Primary Outcome Measures
Subjects' nutritional profiles
Subjects' hemoglobin A1c (A1c) values
Secondary Outcome Measures
Subjects' satisfaction with diabetes treatment
Subjects' self-care behaviors
Full Information
NCT ID
NCT00225888
First Posted
September 22, 2005
Last Updated
April 12, 2017
Sponsor
Joslin Diabetes Center
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00225888
Brief Title
Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
Official Title
Digital Photography and Group Discussion as a Means of Affecting Dietary Change Among People With Type 2 Diabetes: Feasibility Project
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigators left Joslin
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 20, 2007 (Actual)
Study Completion Date
July 20, 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of food photography with group discussions to the effect of regular diabetes nutrition care on people's eating habits, satisfaction with care, self-care behaviors, and blood sugar levels. We hypothesize that, by photographing all meals and snacks (i.e., keeping 'photo journals') and participating in discussions about the photographs with peers and a nutritionist, people with diabetes will become aware of their behaviors and develop concrete strategies to meet nutritional recommendations.
Detailed Description
Diet is critical to effective self-management of diabetes. Thus, people with diabetes receive substantial nutrition counseling as part of their care. Among other things, nutrition counseling can include nutrition facts, information about portions, menus, discussion of barriers to healthy eating, and recommendations to control intake of saturated fats, maintain consistent eating patterns, and distribute nutrient intake throughout the day. Despite the depth and breadth of nutrition counseling, many people with diabetes implement diet changes with limited success.
The overall objective of this study is to test the feasibility of a new approach to diabetes nutrition care, digital food photography and facilitated group discussions. The overall hypothesis regarding this new approach is that, by photographing all meals and snacks (i.e., keeping 'photo journals') and participating in discussions about the photographs with peers and a nutritionist, people with diabetes will become aware of their behaviors and develop concrete strategies to meet nutritional recommendations. This overall hypothesis can be further specified as follows:
People with diabetes who receive the new approach to diabetes nutrition care (i.e., the digital photos with discussions) will show greater improvements in their nutritional profiles and hemoglobin A1c (HbA1c) values (primary clinical outcomes) than people who receive standard diabetes nutrition care.
People with diabetes who receive the new approach to diabetes nutrition care will become more satisfied with their diabetes treatment compared to people who receive standard care (secondary clinical outcome).
People with diabetes who receive the new approach to diabetes nutrition care will show greater improvements in minimizing the barriers that affect their abilities for effective self-care compared to people who receive standard care (secondary outcome).
The study design is that of a single-site, randomized controlled trial with two groups of approximately 18 study participants assigned to each (for a total of 36 study participants). The study will take place at Joslin Diabetes Center. One group will receive standard diabetes nutrition care. The other group will receive the new approach to diabetes nutrition care involving digital photography of meals and group discussion of the photographs. All participants will complete study questionnaires before the study begins and approximately 1 month after the completion of the digital photography discussion groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Nutrition, Digital photography, Self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Digital Photography of meals/snacks and group discussion
Intervention Description
Digital Photography of meals/snacks and group discussion
Primary Outcome Measure Information:
Title
Subjects' nutritional profiles
Time Frame
6 months
Title
Subjects' hemoglobin A1c (A1c) values
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subjects' satisfaction with diabetes treatment
Time Frame
6 months
Title
Subjects' self-care behaviors
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be a patient of the Joslin Diabetes Center
Must have type 2 diabetes
Must be between 30 and 60 years of age
Must have a BMI equal to or greater than 30
Must agree to randomization
Must provide written informed consent
Exclusion Criteria:
Unable to give written informed consent
Unable to communicate in and read English
A severe visual impairment
Pregnancy
Non-compliance or unlikely to return for the treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie J. Fonda, Ph.D.
Organizational Affiliation
Joslin Diabetes Center and Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
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