Type 2 DiabetesNCT00225888
Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
A study testing Digital Photography of meals/snacks and group discussion in people with Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Digital Photography of meals/snacks and group discussion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to 20 Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Photography and Group Discussion as a Means of Affecting Dietary Change Among People With Type 2 Diabetes: Feasibility Project
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Digital Photography of meals/snacks and group discussion
- Keywords
- Diabetes, Nutrition, Digital photography, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Photography of meals/snacks and group discussionBehavioural
Digital Photography of meals/snacks and group discussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects' nutritional profiles
Measured: 6 months
Subjects' hemoglobin A1c (A1c) values
Measured: 6 months
Secondary outcomes (2)
Subjects' satisfaction with diabetes treatment
Measured: 6 months
Subjects' self-care behaviors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startOct 2004
- Primary completion20 Jul 2007
- Study completion20 Jul 2007
Why it stopped: Investigators left Joslin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Investigators
- Stephanie J. Fonda, Ph.D., Principal investigator, Joslin Diabetes Center and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225888
- Sponsor's protocol ID
- CHS #03-47
- Other IDs
- DAMD17-03-2-0062
- Status last verified
- Apr 2017
- First submitted
- 22 Sep 2005
- Last updated
- 13 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Photography and Group Discussion as a Means of Affecting Dietary Change Among People With Type 2 Diabetes: Feasibility Project
- ClinicalTrials.gov ID
- NCT00225888
- Acronym / sponsor ID
- CHS #03-47
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Nutrition, Digital photography, Self-management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators left Joslin
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Oct 2004
- Primary completion
- 20 Jul 2007 (actual)
- Study completion
- 20 Jul 2007 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Photography of meals/snacks and group discussionDigital Photography of meals/snacks and group discussion | Behavioural | – |
Primary outcome
Subjects' nutritional profiles
Time frame: 6 months
Subjects' hemoglobin A1c (A1c) values
Time frame: 6 months
2 secondary outcomes
Subjects' satisfaction with diabetes treatment
Time frame: 6 months
Subjects' self-care behaviors
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Investigators left Joslin). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie J. Fonda, Ph.D. principal investigator
Joslin Diabetes Center and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Photography of meals/snacks and group discussion in people with Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigators left Joslin). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects' nutritional profiles (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.