ObesityNCT02924051
Interventions in Nutrition Education and Skills
A study testing Motivational Interviewing and Cooking skills and nutritional education in people with Obesity, run by Frances Hardin-Fanning, PhD, RN.
Trial summary
Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Motivational Interviewing and Cooking skills and nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People who live in one of six rural Kentucky food desert counties
Who cannot join
- <16 years old
- Unable to read/write English
- Any GI malabsorption disorder that prevents high fiber consumption
About this study
Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability
Read the detailed description
Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.
- Conditions
- Obesity
- Being tested
- Motivational Interviewing, Cooking skills and nutritional education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
Cooking skills and nutritional educationBehavioural
Participants in this group will develop an understanding of healthy food options and healthy food preparation.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview (MI) | Experimental | Intervention group participants receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse Receives: Behavioral: Motivational Interviewing |
| Cooking Skills/Nutritional Education | Active comparator | Participants in this arm receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families. Receives: Behavioral: Cooking skills and nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months
Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.
Measured: Baseline, 12 months
Secondary outcomes (2)
Average Saturated Fatty Acid Intake/Day
Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids.
Measured: Baseline, 12 months
Frequency of Fast Food Consumption
Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control/Intervention Groups (3 sites in each group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frances Hardin-Fanning, PhD, RN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frances Hardin-Fanning, PhD, RN, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924051
- Sponsor's protocol ID
- 14-0020-P2H
- Status last verified
- May 2019
- First submitted
- 3 Oct 2016
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data being compiled
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions in Nutrition Education and Skills
- ClinicalTrials.gov ID
- NCT02924051
- Acronym / sponsor ID
- 14-0020-P2H
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Frances Hardin-Fanning, PhD, RNUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability
Detailed description
Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control/Intervention Groups (3 sites in each group)
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview (MI) | Experimental | Behavioral: Motivational InterviewingIntervention group participants receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse |
| Cooking Skills/Nutritional Education | Active comparator | Behavioral: Cooking skills and nutritional educationParticipants in this arm receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People who live in one of six rural Kentucky food desert counties
Key exclusion criteria (3 listed)
- <16 years old
- Unable to read/write English
- Any GI malabsorption disorder that prevents high fiber consumption
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 |
|---|---|---|
| Motivational InterviewingBaseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. | Behavioural | Motivational Interview (MI) |
| Cooking skills and nutritional educationParticipants in this group will develop an understanding of healthy food options and healthy food preparation. | Behavioural | Cooking Skills/Nutritional Education |
Primary outcome
Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months
Time frame: Baseline, 12 months
Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.
2 secondary outcomes
Average Saturated Fatty Acid Intake/Day
Time frame: Baseline, 12 months
Frequency of Fast Food Consumption
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data being compiled
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Cooking skills and nutritional education in people with Obesity, run by Frances Hardin-Fanning, PhD, RN.
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 1 inclusion and 3 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months (time frame: Baseline, 12 months). 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 22 Jul 2019.