ObesityNCT02124135
Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
A study testing Diet/Nutrition Education in people with Obesity, run by Kaiser Permanente at 1 site in United States.
Trial summary
Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. Read more about this study
- Who is it for?
- Ages 8 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- Diet/Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2014
- 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 8 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adult member of Kaiser Georgia, in a specific employer group
- families in which at least one parent and one child are obese
- family with 2 or fewer children all between 8-13 years of age
- no-show rate for clinic visits <10%
- adult is 18-64 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research, Southeast
Atlanta, Georgia, 30305
About this study
Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.
We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:
Read more
- Change in dietary measures
- Nutritional knowledge of families
- Participant self-efficacy and confidence in food purchasing decisions
- Participant and dietician perception of visit
We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.
Read the detailed description
Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.
Our study population will come from a local employer group, and we will use the electronic medical record to identify families where at least one child and one parent are affected by obesity. Assuming families are interested and meet eligibility criteria, they will be enrolled in the study.
Our study design is a randomized trial, where randomization occurs at the unit of the family. 45 families will be randomized into one of two arms. All families will receive a baseline 30 minute phone call with the dietitian, followed by three in-person group visits. Those in the intervention (Eat Out) arm will have their in-person visits conducted during mealtimes at a restaurant. Those in the control (clinic) arm will have their in-person visits conducted in a classroom at a Kaiser medical office building.
We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:
- Change in dietary measures including - Fruit and Vegetable Intake, Whole Grain Intake, Saturated Fat Intake and Added Sugars.
- Nutritional knowledge of families
- Participant self-efficacy and confidence in food purchasing decisions - all family members
- Participant and dietician perception of visit type (attendance, feasibility, effectiveness, e.g.)
We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.
- Conditions
- Obesity
- Being tested
- Diet/Nutrition Education
- Keywords
- Nutrition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet/Nutrition EducationBehavioural
As described elsewhere, all participants will receive 1 phone call and 3 in person sessions with the registered dietitian.
Participants in the "clinic" arm will receive the education intervention in the clinic.
Participants in the "restaurant" arm will receive the education intervention while dining in a restaurant.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based counseling | Active comparator | Participants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in the clinic setting. Receives: Behavioral: Diet/Nutrition Education |
| Restaurant-based counseling | Experimental | Participants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in a restaurant, while dining. Receives: Behavioral: Diet/Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fruit and Vegetable Intake
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Measured: 3 months
Change in Whole Grain Intake
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Measured: 3 months
Change in Saturated Fat Intake
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Measured: 3 months
Change in Added Sugars Intake
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Measured: 3 months
Secondary outcomes (2)
Change in Nutritional Knowledge of Families
Will be assessed using a modified version of previously validated nutritional knowledge from the UK. Total possible score of 65 points. Covers topics such as recommendations from experts, types of fat, foods high in sodium, added sugar, fiber and fat.
Measured: 3 months
Self-efficacy around food purchasing and dietary decisions
Will be assessed using a series of questions about how confident a participant feels about his / her ability to change food and dietary behaviors in the near future. Paper survey to be administered to one adult per participating family.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Lewis, Kaiser Permanente
- Investigators
- Kristina H Lewis, MD MPH SM, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124135
- Sponsor's protocol ID
- Pro00004774
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
- ClinicalTrials.gov ID
- NCT02124135
- Acronym / sponsor ID
- Pro00004774
- Conditions
- Obesity
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Apr 2014 (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.
Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.
We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:
- Change in dietary measures
- Nutritional knowledge of families
- Participant self-efficacy and confidence in food purchasing decisions
- Participant and dietician perception of visit
We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.
Detailed description
Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.
Our study population will come from a local employer group, and we will use the electronic medical record to identify families where at least one child and one parent are affected by obesity. Assuming families are interested and meet eligibility criteria, they will be enrolled in the study.
Our study design is a randomized trial, where randomization occurs at the unit of the family. 45 families will be randomized into one of two arms. All families will receive a baseline 30 minute phone call with the dietitian, followed by three in-person group visits. Those in the intervention (Eat Out) arm will have their in-person visits conducted during mealtimes at a restaurant. Those in the control (clinic) arm will have their in-person visits conducted in a classroom at a Kaiser medical office building.
We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:
- Change in dietary measures including - Fruit and Vegetable Intake, Whole Grain Intake, Saturated Fat Intake and Added Sugars.
- Nutritional knowledge of families
- Participant self-efficacy and confidence in food purchasing decisions - all family members
- Participant and dietician perception of visit type (attendance, feasibility, effectiveness, e.g.)
We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based counseling | Active comparator | Behavioral: Diet/Nutrition EducationParticipants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in the clinic setting. |
| Restaurant-based counseling | Experimental | Behavioral: Diet/Nutrition EducationParticipants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in a restaurant, while dining. |
Who may qualify
- Ages
- 8 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- adult member of Kaiser Georgia, in a specific employer group
- families in which at least one parent and one child are obese
- family with 2 or fewer children all between 8-13 years of age
- no-show rate for clinic visits <10%
- adult is 18-64 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diet/Nutrition EducationAs described elsewhere, all participants will receive 1 phone call and 3 in person sessions with the registered dietitian. Participants in the "clinic" arm will receive the education intervention in the clinic. Participants in the "restaurant" arm will receive the education intervention while dining in a restaurant. | Behavioural | Clinic-based counseling, Restaurant-based counseling |
Primary outcome
Change in Fruit and Vegetable Intake
Time frame: 3 months
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Change in Whole Grain Intake
Time frame: 3 months
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Change in Saturated Fat Intake
Time frame: 3 months
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
Change in Added Sugars Intake
Time frame: 3 months
Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.
2 secondary outcomes
Change in Nutritional Knowledge of Families
Time frame: 3 months
Self-efficacy around food purchasing and dietary decisions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
Kristina H Lewis, MD MPH SM principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet/Nutrition Education in people with Obesity, run by Kaiser Permanente 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 18 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Fruit and Vegetable Intake (time frame: 3 months). The study lists 4 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 18 Aug 2017.