Dietary Advice on Prescription in Kungsbacka

NCT01385930 | Unknown

• 1 other identifier: Halm30118
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight

Keywords

Overweight; Obesity; lifestyle counseling

Outcome Measures

Primary Outcomes (1)

• BMI

  Lifestyle intervention

  two years

Secondary Outcomes (1)

• LDL cholesterol

  two years

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Lifestyle counseling

Behavioral: Lifestyle counseling

Control group

NO INTERVENTION

Control group

Interventions

Lifestyle counseling BEHAVIORAL

Lifestyle counseling

Lifestyle counseling

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 28-35

You may not qualify if:

• Severe disease

Sponsors & Collaborators

• Halmstad University: lead
• Carema: collaborator
• Region Halland: collaborator

Study Sites (1)

Carema husläkarna

Kungsbacka, Halland County, 434 30, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marie Ewe, Nurse

CONTACT

0733-132999; Marie.Brautigam-Ewe@lthalland.se

Jörgen Månsson, MD

CONTACT

0705-776711; Jorgen.Mansson@carema.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: July 4, 2011

Record last verified: 2011-03

Locations

SE (1)