- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225888
Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
Digital Photography and Group Discussion as a Means of Affecting Dietary Change Among People With Type 2 Diabetes: Feasibility Project
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects' nutritional profiles
Time Frame: 6 months
|
6 months
|
Subjects' hemoglobin A1c (A1c) values
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects' satisfaction with diabetes treatment
Time Frame: 6 months
|
6 months
|
Subjects' self-care behaviors
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie J. Fonda, Ph.D., Joslin Diabetes Center and Harvard Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHS #03-47
- DAMD17-03-2-0062
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.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Digital Photography of meals/snacks and group discussion
-
Pennington Biomedical Research CenterCompleted
-
Marmara UniversityEnrolling by invitationTooth DiscolorationTurkey
-
Masonic Cancer Center, University of MinnesotaCompletedAllogeneic HCT SurvivorsUnited States
-
University of RochesterNational Institutes of Health (NIH)CompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3United States
-
Biokosmes SrlOpera CRO, a TIGERMED Group CompanyCompletedOral Hygiene | Dental Plaque | ToothbrushingItaly
-
University Hospital Inselspital, BerneCompletedCoronary Artery Disease | STEMI - ST Elevation Myocardial InfarctionItaly, Switzerland
-
Nitric BioTherapeutics, IncTerminated
-
Dow University of Health SciencesCompletedApical Periodontitis | Irreversible Pulpitis | Root Canal InfectionPakistan
-
Mercy Medical CenterActive, not recruitingPseudomyxoma Peritonei | Appendiceal NeoplasmsUnited States