NC: Cardiovascular Disease Risk Factors (2007-2008)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
- To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care
- To assess the suitability of the program for use in the health centers of the City of Turku Area Health Authority.
Inclusion Criteria:
Overweight patients (aged 17 to 65 years, minimum BMI 27.0kg per m2) from the health centers.
Exclusion Criteria:
Patients with diabetes or other disease which prevented them from complying with the weight reduction program in its present form.
Description of Study Protocol:
Recruitment
Six months before onset of the study general practitioners recruited overweight patients for the study.
Design
Objective 1
- To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care
- During intervention (year one), subjects were randomly assigned to the treatment or control, but it is unclear if they were randomly selected from the population (article only states that they were recruited)
- The seven-year period follow-up on weight changes were for treatment group only (year one, two, 3.5, five and seven).
Objective 2
- To assess the suitability of the program for use in the health centers of the City of Turku Area Health Authority
- Upon completion of the weight reduction course, questionnaire was sent to public health nurses in charge of groups to evaluate experiences in the running of their course, as well as to list any problems and to give their proposals for any changes in the program
- Questionnaires were also sent to treatment subjects asking them to give their opinions about the content and length of the course and to give suggestions for any changes.
Blinding Used
None.
Intervention
- Treatment: Weight reduction program and diet
- Treatment group was divided into eight sub-groups, each with 12 to18 participants and lead by a public health nurse
- Sessions were 1.5 hour for six weeks, followed by monthly meetings for four months, then twice every second month
- Nutrition education and dietary counseling was provided on a 1,200kcal diet based on ordinary Finnish foods and meal patterns and to modify counterproductive dietary habits
- Diet was low in fats and sugar, moderate in milk products, cereals, meat and fish and high in vegetables
- Meal pattern was breakfast, lunch, dinner and a snack in the afternoon and evening
- Three separate lectures by a physician, a psychologist and a physiotherapist, encouraging and supporting the subjects in their weight reduction efforts
- Control: No instructions. Subjects were told they had not been selected for the first weight reduction course, but to a later one to begin a year later.
Statistical Analysis
- One-sample T-test utilized to asses significance of changes in food consumption and nutrient intake, weight, blood pressure and serum cholesterol levels in the treatment group and in the control group during the intervention year (within group changes)
- Two-sample T-test utilized to test the hypotheses of differences between treatment and control groups for changes in food consumption and nutrient intake, weight, blood pressure and serum cholesterol levels
- One-sample T-test utilized to assess significance of weight changes in the treatment group over the seven-year follow-up period.
Data Collection Summary:
Timing of Measurements
- Objective 1: To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care
- Onset
- Height
- Weight
- Blood pressure
- Total cholesterol and HDL
- Food consumption (via diet history interview by dietitian); calculations were made with 21 food groups and 17 nutrients, including food energy and cholesterol, using a nutrient data bank and a computer system designed for nutrition research at the SII
- Physical activity (via questionnaire in conjunction with diet interview).
- Weekly for six weeks: Weight
- Monthly for four months after first six weeks: Weight
- Twice at two-month intervals after the four monthly weighings: Weight
- One year: Weight, blood pressure, cholesterol level, food consumption, physical exercise level
- At two years, 3.5, five and seven years: Weight (in-person or via mail or telephone)
- Onset
- Objective 2:
- To assess the suitability of the program for use in the health centers of the City of Turku Area Health Authority
- End of weight reduction courses: Questionnaires from public health nurse course leaders and treatment participants.
Dependent Variables
- Objective 1: To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care
- Variable 1: Body weight measured at an accuracy of 100g with subjects wearing light, indoor clothing and without shoes
- Variable 2: Blood pressure measured in right arm of seated subject by auscultatory method after a minimum of 10-minute rest; repeated five minutes later and lower of two readings recorded
- Variable 3: Cholesterol measurement (total cholesterol and HDL measured without fasting (as subjects were tested at different times of the day) via enzymatic technique
- Variable 4: Food consumption via diet history interview on 21 food groups and 17 nutrients, including food energy and cholesterol
- Variable 5: Physical activity as measured by questionnaire
- Objective 2: To assess the suitability of the program for use in the health centers of the City of Turku Area Health Authority. Course evaluation as measured by data obtained from a questionnaire.
Independent Variables
Objective 1
- To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care
- IV - group (treatment or control)
- IV - gender (male or female).
Control Variables
- None mentioned.
Description of Actual Data Sample:
- Initial N: 243 (N=126 treatment group; N=117 control group)
- Attrition (final N): 189
- N=93 treatment group (24% male, 76% female)
- N=96 control group (21% male, 79% female)
- Age at onset: 48.5 years treatment group; 47.8 years control group
- Ethnicity: Presumed Finnish
- Other relevant demographics: None mentioned
- Anthropometrics: BMI: 34.3kg per m2 treatment group - 33.5kg per m2 control group
- Location: City of Turku, Finland.
Summary of Results:
Objective 1
To assess the short- and long-term effects of a Finnish Social Insurance Institution (SII) weight reduction program in groups of overweight clients from primary health care.
Dependent Variable
Body weight change.
|
Treatment Group (within) Changes in Weight |
||||
|
Follow-up |
Number of Subjects |
Mean Weight (kg) |
Mean Weight Loss (kg) |
Significance of Change vs. Baseline (P) |
|
Men |
|
|
|
|
|
Baseline |
17 |
101.0 |
|
|
|
One year |
17 |
90.1 |
10.9 |
<0.01 |
|
Two years |
17 |
88.9 |
12.1 |
<0.01 |
|
3.5 years |
14 |
91.2 |
11.7 |
<0.05 |
|
Five years |
16 |
89.9 |
11.2 |
<0.01 |
|
Seven years |
17 |
92.3 |
8.7 |
<0.05 |
|
|
|
|
|
|
|
Women |
|
|
|
|
|
Baseline |
62 |
90.3 |
|
|
|
One year |
62 |
84.9 |
5.4 |
<0.001 |
|
Two years |
61 |
85.6 |
5.0 |
<0.001 |
|
3.5 years |
58 |
86.1 |
3.4 |
<0.001 |
|
Five years |
57 |
87.4 |
2.9 |
<0.01 |
|
Seven years |
62 |
86.7 |
3.5 |
<0.01 |
|
|
|
|
|
|
Control group experienced weight gain of 0.9kg in men and 0.2kg in women.
|
Between Group Changes in Weight at End of Intervention Period (One Year) |
||
|
|
Weight Change |
Significance of Change Between Groups Per Gender (P<0.001) |
|
Treatment |
|
|
|
Men |
-10.9kg |
* |
|
Women |
-5.4kg |
* |
|
Control |
|
|
|
Men |
+0.9kg |
* |
|
Women |
+0.2kg |
* |
Dependent Variable
Blood pressure.
|
Systolic and Diastolic Blood Pressure at Baseline and at End of One-year Intervention |
|||||
|
Blood Pressure (mmHg) |
Treatment Group |
Control Group |
Significance of difference in change between groups |
||
|
At baseline X±SD |
After one year X±SD |
At baseline X±SD |
After one year X±SD |
||
|
Women |
N=69 |
|
N=76 |
|
|
|
Systolic |
146±20 |
140±19* |
142±19 |
142±21 |
P<0.05 |
|
Diastolic |
92±10 |
86±10*** |
91±11 |
88±10** |
NS |
|
|
|
|
|
|
|
|
Men |
N=22 |
|
N=20 |
|
|
|
Systolic |
145±24 |
145±23 |
148±21 |
147±25 |
NS |
|
Diastolic |
95±20 |
88±15 |
92±12 |
87±11* |
NS |
|
|
|
|
|
|
|
|
Significance of change within group: *P<0.05; **P<0.01; ***P<0.001 |
|||||
Dependent Variable
Cholesterol.
|
S Cholesterol and HDL Cholesterol in the Treatment and in the Control Group
|
|||||
|
Cholesterol
(mmol/l)
|
Treatment Group
|
Control Group
|
Significance of difference in change between groups
|
||
|
At baseline
X±SD
|
After one year
X±SD
|
At baseline
X±SD
|
After one year
X±SD
|
||
|
Women
|
N=71
|
|
N=76
|
|
|
|
S cholesterol
|
5.7±1.2
|
5.9±1.1*
|
5.6±1.4
|
5.9±1.4
|
NS
|
|
HDL
|
1.15±0.3
|
1.33±0.3***
|
1.20±0.4
|
1.24±0.4
|
P<0.001
|
|
|
|
|
|
|
|
|
Men
|
N=22
|
|
N=20
|
|
|
|
S cholesterol
|
5.2±1.3
|
5.4±0.9
|
5.5±1.3
|
5.7±1.1
|
NS
|
|
HDL
|
0.87±0.23
|
1.12±0.33**
|
1.01±0.20
|
1.03±0.20
|
P<0.01
|
Significance of change within group: *P<0.05; P<0.01; ***P<0.001
Dependent Variable
Food consumption during one-year intervention. Note: This section is very unclear. Sometimes groups refers to treatment and control and sometimes groups refers to men and women.
Treatment Group
- Mean consumption of butter reduced 56% in men and 46% in women
- Men and women reduced their margarine consumption by more than 30%
- Consumption of high-fat milk products, high-fat meat products and other foods high in fats was reduced and intake of fat reduced by 38%
- Proportion of fat of the total energy of the diet reduced from 41% to 34% in women and to 35% in men
- Total energy intake diminished by 29% in the treatment group and by about 15% in the control group
- Vitamin C intake increased, but intake of other vitamins and minerals decreased (intake levels were adequate compared to the RDAs), except that niacin intake in men was slightly lower than recommended
Control Group
- Women slightly reduced their food consumption
- Consumption of butter remained at about the same level in both sexes, but men tended to increase their consumption of some other fat-containing foods
- Total energy intake diminished by about 15%
- Intake of fat reduced by 19%
Statistical Significance
- None in nutrient intake between at beginning of study
- At end of intervention year, statistical differences seen in the intake of sucrose (P<0.001), energy, carbohydrates and saturated fatty acids (P<0.05) between women in the treatment group and in the control group
- Men showed a significant difference between the treatment and the control group in the intake of saturated fatty acids (P<0.05).
Dependent Variable
Physical Activity
- During the intervention year physical activity levels increased in 21% of women in the treatment group and in 8% of those in the control group
- During the intervention year physical activity levels increased in 28% of men in the treatment group and in 10% of those in the control group.
Objective 2
To assess the suitability of the program for use in the health centers of the City of Turku Area Health Authority
- 100% percent participation by public health nurse group leaders (N=7).
- They felt the course was useful and applicable to primary health care, but too short considering its extensive content
- They recommended extending the six-week course to 10 weeks, with no more than 10 to12 participants per treatment group
- 86% of subjects in treatment group completed the questionnaire
- The majority felt the course met or exceeded their expectations
- Fifty-eight percent felt the course was too short and the remainder felt the course length was suitable
- The course was considered well-planned, interesting and relevant
- The majority felt the lessons were good. Support of the other members of the group was found important for successful weight reduction.
Author Conclusion:
- The greatest weight reductions are usually achieved during the intervention period; the group has a favorable effect on its members and motivates them in their efforts at weight reduction
- 71% of the subjects losing weight during the intervention year have succeeded in maintaining their reduced weight rather well for many years most likely due to the weight reduction program, specifically, the daily diet and meal pattern which was introduced to the subjects
- Practical methods were used in teaching the art of weight reduction; only one pattern of daily diet and various ways of modifying it by means of a simple exchange list of foods were taught; the principle idea was to make the new meal pattern easy to adopt.
- 1,200kcal diet adequate for weight loss and could be easily modified for weight maintenance at a later date
- The fact that the weight reduction results were better in men than in women can partly be due to the equal energy level of their recommended diet
- The favorable weight reduction results could also be explained by the strong support of the group leaders and the regular weight measurement sessions during the intervention year
- Weight reduction courses in primary health care are thus important in lowering the health risks of the population.
Funding Source:
| Government: | Social Insurance Institution (Finland) |
Reviewer Comments:
- During intervention (one year), RCT random assignment to treatment or control, but it is unclear if there was random selection from population as in a true RCT. There was a treatment group only cohort follow-up for weight changes.
- Presentation of data was difficult to interpret in several instances. I was looking for tabulated data consistent with the statistical analysis discussed.
|
Quality Criteria Checklist: Primary Research
|
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| Relevance Questions | |||
| 1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
| 2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
| 3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
| 4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
| Validity Questions | |||
| 1. | Was the research question clearly stated? | Yes | |
| 1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
| 1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
| 1.3. | Were the target population and setting specified? | Yes | |
| 2. | Was the selection of study subjects/patients free from bias? | Yes | |
| 2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | Yes | |
| 2.2. | Were criteria applied equally to all study groups? | Yes | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
| 2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
| 3. | Were study groups comparable? | Yes | |
| 3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | No | |
| 3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | Yes | |
| 3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | Yes | |
| 3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
| 3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
| 3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
| 4. | Was method of handling withdrawals described? | Yes | |
| 4.1. | Were follow-up methods described and the same for all groups? | Yes | |
| 4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | Yes | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
| 4.4. | Were reasons for withdrawals similar across groups? | Yes | |
| 4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
| 5. | Was blinding used to prevent introduction of bias? | No | |
| 5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | No | |
| 5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | N/A | |
| 5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
| 5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
| 5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
| 6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | Yes | |
| 6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | Yes | |
| 6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
| 6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
| 6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | Yes | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
| 6.6. | Were extra or unplanned treatments described? | Yes | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | Yes | |
| 6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
| 7. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
| 7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
| 7.2. | Were nutrition measures appropriate to question and outcomes of concern? | Yes | |
| 7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | Yes | |
| 7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | Yes | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | Yes | |
| 7.7. | Were the measurements conducted consistently across groups? | Yes | |
| 8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
| 8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
| 8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
| 8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
| 8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | Yes | |
| 8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | Yes | |
| 8.6. | Was clinical significance as well as statistical significance reported? | Yes | |
| 8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | Yes | |
| 10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
| 10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |