OverweightDAP_KNCT01385930
Dietary Advice on Prescription in Kungsbacka
A study testing Lifestyle counseling in people with Overweight, run by Halmstad University at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate self-reported adherence to and the effects of an intervention model consisting of individualized prescribed dietary advice (DAP) in combination with Motivational Interviewing (MI), social support and mobile services in obese patients in primary health care. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Dec 2015
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 28-35
Who cannot join
- Severe disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Carema husläkarna
Kungsbacka, Halland County, 434 30
Marie Ewe, Nurse, 0733-132999, Marie.Brautigam-Ewe@lthalland.se
Jörgen Månsson, MD, 0705-776711, Jorgen.Mansson@carema.se
About this study
Official title: A New Concept for Lifestyle Change, Dietary Advice on Prescription (DAP) in Combination With Motivational Interviewing (MI), Social Support and Mobile Services
The aim of the study is to evaluate self-reported adherence to and the effects of an intervention model consisting of individualized prescribed dietary advice (DAP) in combination with Motivational Interviewing (MI), social support and mobile services in obese patients in primary health care. The specific aim is to relate effects of the intervention model to self-reported health, biomarkers for coronary heart disease, diabetes, some cancer forms, sleep duration and quality, health economy, oral health, dietary intake and physical activity.
This is a two-armed randomized controlled study. The arms are: 1) Control group (care as usual) and 2) Experimental group (MoR). The volunteers will be consecutively, for each sex, randomized to the experimental and the control group, respectively.
Read more
The experimental group will receive DAP together with Motivational interviewing up to six months after the start of the study. From six months up to 24 months the participants will receive social support online and mobile services.
The control group will receive dietary information according to the "Habo model". The previously mentioned diet will be recommended to both the control group and the experimental group since it is the method in which the investigators give the information they want to study and not the diet per se. Thus, it is only the way the investigators give dietary information that differs between the groups.
The study also includes qualitative interviews. The aim of these studies is to gain understanding of patients' and health professionals' experience and attitudes around food, lifestyle and support functions associated with dietary change. The sampling approach involves the purposeful selection of cases with a wide range of variation, which means that the researcher selects people who are able to provide rich information about the current issue. To achieve diversity, it is useful that both women and men are involved in the studies, as well as people of different ages and with different experiences of providing or receiving dietary advice. About 15-20 people will participate in each interview study.
Read the detailed description
The investigators assume a difference in BMI (body mass index; kg/m x m) of 2 units, a standard deviation of 4.5 units, a power of 80 %, an alfa error of 5 % I a two-tailed test, the investigators would need at least 80 individuals in the experimental group and in the control group, respectively.
With 80 individuals in each group and the assumption of 5 % adherence (4 individuals) in the control group, the investigators would be able to detect an adherence of 21 % or higher (at least 17 individuals) in the experimental group with 80 % power. The alfa error is set to 5 % in a two-tailed test with the null hypothesis that the adherence is the same in both groups.
Therefore the investigators plan a study with at least 100 individuals in each group and assume that 20 % will not complete the study.
The evaluation of the quantitative studies will be performed in three ways: 1) Process evaluation, that will focus on intermediate outcomes such as knowledge, attitudes, motivation and readiness for change. 2) Effect evaluation will be used to evaluate the effect of the intervention programme on the subjects' behavior such as dietary intake and physical activity level. 3) Outcome evaluation will measure the total effect of the intervention programme, in this case variables that measures indicators for health and disease, such as SF-36, EQ-5D, SHIS, serum cholesterol, blood pressure, BMI, waist circumference etc.
Intention-to-treat (ITT) analysis will be used to assess effects on outcome measures. Variables not normally distributed will be logarithmically transformed. Paired t-test will be used to assess change within groups and unpaired t-tests to compare mean changes between groups. Non-parametric statistics, Wilcoxon Signed Ranks Test and Mann-Whitney U-Test will be used for ordinal data such as questionnaires. Two-tailed tests will be used and a p-value less than 0.05 will be considered statistically significant.
Qualitative data will be analyzed by content analysis.
- Conditions
- Overweight
- Being tested
- Lifestyle counseling
- Keywords
- Overweight, Obesity, lifestyle counseling
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
Lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Lifestyle counseling Receives: Behavioral: Lifestyle counseling |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Lifestyle intervention
Measured: two years
Secondary outcomes (1)
LDL cholesterol
Lifestyle intervention
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halmstad University
- Sponsor type
- University, hospital or other
- Collaborators
- Carema, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385930
- Sponsor's protocol ID
- Halm30118
- Acronym
- DAP_K
- Status last verified
- Mar 2011
- First submitted
- 29 Jun 2011
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Concept for Lifestyle Change, Dietary Advice on Prescription (DAP) in Combination With Motivational Interviewing (MI), Social Support and Mobile Services
- ClinicalTrials.gov ID
- NCT01385930
- Acronym / sponsor ID
- DAP_K / Halm30118
- Conditions
- Overweight
- Keywords
- Overweight, Obesity, lifestyle counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Halmstad UniversityUniversity, hospital or other
- Collaborators
- Carema, Region Halland
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jun 2011 (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 aim of the study is to evaluate self-reported adherence to and the effects of an intervention model consisting of individualized prescribed dietary advice (DAP) in combination with Motivational Interviewing (MI), social support and mobile services in obese patients in primary health care. The specific aim is to relate effects of the intervention model to self-reported health, biomarkers for coronary heart disease, diabetes, some cancer forms, sleep duration and quality, health economy, oral health, dietary intake and physical activity.
This is a two-armed randomized controlled study. The arms are: 1) Control group (care as usual) and 2) Experimental group (MoR). The volunteers will be consecutively, for each sex, randomized to the experimental and the control group, respectively.
The experimental group will receive DAP together with Motivational interviewing up to six months after the start of the study. From six months up to 24 months the participants will receive social support online and mobile services.
The control group will receive dietary information according to the "Habo model". The previously mentioned diet will be recommended to both the control group and the experimental group since it is the method in which the investigators give the information they want to study and not the diet per se. Thus, it is only the way the investigators give dietary information that differs between the groups.
The study also includes qualitative interviews. The aim of these studies is to gain understanding of patients' and health professionals' experience and attitudes around food, lifestyle and support functions associated with dietary change. The sampling approach involves the purposeful selection of cases with a wide range of variation, which means that the researcher selects people who are able to provide rich information about the current issue. To achieve diversity, it is useful that both women and men are involved in the studies, as well as people of different ages and with different experiences of providing or receiving dietary advice. About 15-20 people will participate in each interview study.
Detailed description
The investigators assume a difference in BMI (body mass index; kg/m x m) of 2 units, a standard deviation of 4.5 units, a power of 80 %, an alfa error of 5 % I a two-tailed test, the investigators would need at least 80 individuals in the experimental group and in the control group, respectively.
With 80 individuals in each group and the assumption of 5 % adherence (4 individuals) in the control group, the investigators would be able to detect an adherence of 21 % or higher (at least 17 individuals) in the experimental group with 80 % power. The alfa error is set to 5 % in a two-tailed test with the null hypothesis that the adherence is the same in both groups.
Therefore the investigators plan a study with at least 100 individuals in each group and assume that 20 % will not complete the study.
The evaluation of the quantitative studies will be performed in three ways: 1) Process evaluation, that will focus on intermediate outcomes such as knowledge, attitudes, motivation and readiness for change. 2) Effect evaluation will be used to evaluate the effect of the intervention programme on the subjects' behavior such as dietary intake and physical activity level. 3) Outcome evaluation will measure the total effect of the intervention programme, in this case variables that measures indicators for health and disease, such as SF-36, EQ-5D, SHIS, serum cholesterol, blood pressure, BMI, waist circumference etc.
Intention-to-treat (ITT) analysis will be used to assess effects on outcome measures. Variables not normally distributed will be logarithmically transformed. Paired t-test will be used to assess change within groups and unpaired t-tests to compare mean changes between groups. Non-parametric statistics, Wilcoxon Signed Ranks Test and Mann-Whitney U-Test will be used for ordinal data such as questionnaires. Two-tailed tests will be used and a p-value less than 0.05 will be considered statistically significant.
Qualitative data will be analyzed by content analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingLifestyle counseling |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 28-35
Key exclusion criteria (1 listed)
- Severe disease
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 |
|---|---|---|
| Lifestyle counselingLifestyle counseling | Behavioural | Lifestyle counseling |
Primary outcome
BMI
Time frame: two years
Lifestyle intervention
1 secondary outcome
LDL cholesterol
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Overweight, run by Halmstad University at 1 site in Sweden.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Jul 2011. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Ewe, Nurse (0733-132999, Marie.Brautigam-Ewe@lthalland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: two years). 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 4 Jul 2011.