MNT: Weight Management (2015)

Citation:

Melin I, Karlström B, Lappalainen R, Berglund L, Mohsen R, Vessby B. A program of behavior modification and nutrition counseling in the treatment of obesity: A randomized two-year clinical trial. Int J Obes Relat Metab Disord. 2003 Sep; 27 (9): 1,127-1,135.

PubMed ID: 12917721
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  • Aim: To explore whether intensive treatment produced greater weight loss and weight stability, compared with less-intensive treatment
  • To define a reasonable level of input from health care personnel to reach adequate treatment results.
Inclusion Criteria:
  • Patients referred to clinic due to obesity with complications and diagnoses like diabetes mellitus Type 2, hypertension, dyslipoporteinaemia, polycystic ovary disease and sleep apnea
  • Meeting with physician for initial medical examination and discussion of treatment offered
  • Individual meeting with the dietitian
  • Attended an information meeting where they decided if they wanted to participate; signed consent forms
  • Signed contract with obligations between clinic and patients outlined.
Exclusion Criteria:
None mentioned.
Description of Study Protocol:
  • Compared two group treatment programs for obese outpatients
  • Both programs included behavior modification, nutrition counseling, very-low-calorie diet (VLCD) and continuous measuring of metabolic and anthropometrical status
  • Levels of intensity varied.

Treatment Program

  1. Four-day food record by household measures
  2. VLCD
    • The VLCD periods were 25 days
    • The subjects were instructed to decrease their energy intake successively during three days from 800kcal down to a level of approximately 200kcal per day and to keep this intake during the following 19 days
    • The energy intake was progressively increased again to 800kcal per day during the last three days of the VLCD period
    • The subjects were instructed to drink liquids every two hours
    • The liquid prescribed consisted of water, herbal tea, different kinds of fruit and vegetable juice.
  3. Dietary treatment
    • After the VLCD period, ordinary food was gradually introduced
    • All subjects were prescribed an individualized hypocaloric diet aiming at an energy deficit of approximately 600kcals per day
    • Education in nutrition and food habits was given and self-monitoring and strategies to control eating behavior were discussed.
  4. Health education: Meetings included the whole family and included information on risk factors of being obese, connections between food, health and disease, metabolism, appetite control and medical risk factors and basic facts about energy and the ABCs of nutrition.
  5. Behavior treatment
    • Self-monitoring was used as a tool to follow the behavior change process
    • Participants evaluated progress and identified personal and environmental influences that regulate eating and physical activity
    • The focus was on eating behavior, hunger and craving, relapse situations, physical activities and satisfaction and happiness.

Recruitment

Participants were recruited after they were referred to the clinic, due to obesity.

Design

Two-year randomized clinical trial (RCT).

Intervention

Participants were randomized to one of two treatment groups: More intense (Group One) and less intense (Group Two), according to gender, age and BMI.

  • Group One: Continuous intensive treatment with planned group meetings every fortnight during the first year and six meetings during the second year for a total of 43 meetings in two years. More intensive care, including the possibility to repeat the self-monitoring and obtain more information and education in nutrition, food habits and strategies to control the eating behavior.
  • Group Two: Met less often, with planned group meetings every third month for a total of 27 meetings in two years. Less contact with supervisors, fewer repetitions with self-monitoring and less possibilities of nutrition counseling.

Statistical Analysis

  • Based on treatment effects or high or low attendance (change from baseline) to three, six, 12 and 24 months within and between groups via paired and unpaired T-tests, two-tailed, P<0.05
  • Data log transformed if skewed, as defined as W<0.95 in Shapiro-Wilk's test
  • 95% confidence intervals also presented for weight reduction and attendance.
Data Collection Summary:

Timing of Measurements

Anthropometric and metabolic measures baseline and every third month up to 24 months.

Dependent Variables 

  • Variable One: Body weight, as measured in kilograms on a digital scale without shoes and with light clothing, with an accuracy of 0.1kg
  • Variable Two: Body mass index, calculated as body weight divided by height (in meters rounded to 0.5cm), squared
  • Variable Three: Systolic blood pressure (mmHg) in right arm with a sphygmomanometer, cuff size 15.45cm, recordings to the nearest 2.0mmHg, twice after 10 minutes' supine rest and the mean of the two measurements was used in the analysis
  • Variable Four: Diastolic blood pressure (mmHg) in right arm with a sphygmomanometer, cuff size 15.45cm, recordings to the nearest 2.0mmHg, twice after 10 minutes' supine rest and the mean of the two measurements was used in the analysis
  • Variable Five: Fasting plasma glucose (mmol per L), by glucose oxidase method
  • Variable Six: Fasting plasma insulin (mU per L), by the Phadebas test (Pharmacia, Uppsala, Sweden).

Independent Variables 

  • Treatment group (more intense Group One vs. less intense Group Two) 
  • Attendance (high vs. low): High defined as two-thirds (over 60%) compliance at all treatment interventions
  • Time: Baseline, three, six , 12 and 24 months).

Control Variables

None. 

Description of Actual Data Sample:

Initial N

  • 43 subjects (39 female, four male)
  • Group One: 22 subjects
  • Group Two: 21 subjects.

Attrition (Final N)

  • 32
  • Group One: 17 subjects
  • Group Two: 15 subjects) (26%).

Age

  • Group One: 40.7 (25 to 60)
  • Group Two: 39.4 (26 to 57).

Ethnicity

Swedish.

Other Relevant Demographics

All had previous treatment for obesity; groups similar on all demographic characteristics.

Anthropometrics

Groups similar on all anthropometric characteristics.

Location

Sweden.

Summary of Results:

IV: Attendance (High vs. Low) and Weight Reduction (kg)

Variables

High (N=21)
Mean/SEM
CI (changes from baseline)

Low (N=11)
Mean/SEM
CI (changes from baseline)

Statistical Significance of Group Difference
95% CI (changes from baseline)

Weight reduction in 12 months (kg)

-7.4 (8.7)

 

4.5 (5.5)

None
(CI =-3.0-8.8)

Weight reduction in 24 months (kg)

-8.0 (8.4)

-4.1 (6.9)
-1.4-9.2

None
(CI = -1.4-9.2)

IV: Treatment Group One (more intense) N=17 vs. Group Two (less intense) N=15
IV: Time (baseline, three, six, 12 and 24 months.

Variables Group Baseline 3 Months 6 Months 12 Months 24 Months
Dependent Variable One Body weight (kg) One 99.8 (5.5) -8.3 (0.64)*** -10.6 (0.64) *** -7.58 (0.98)*** -6.8 (1.4)**
Two 93.4 (4.1) -10.0 (0.71)*** -12.3 (0.71)*** -6.4 (1.16)*** -8.6 (1.6)**
95% CIa -0.5-3.9 -0.5-3.9 -4.7-2.6 -3.0-6.6
Dependent Variable Two BMI (kg/m2) One 36.3 (1.2) -3.0 (0.25)*** -3.8 (0.23)*** -2.6 (0.35)*** -2.4 (0.5)**
Two 34.0 (1.1) -3.5 (0.28)*** -4.3 (0.27)*** -2.2 (0.42)*** -2.9 (0.6)**
Dependent Variable Three
 
Systolic BP (mmHg)
One 129.0 (3.6) -6.9 (6.65) -8.1 (2.6)* -5.0 (3.0) -9.8 (4.15)*
Two 127.4 (2.7) -2.4 (9.78) -2.1 (2.9) -0.4 (3.6) +2.2 (3.9)
Dependent Variable Four Diastolic BP (mm Hg) One 83.2 (1.6) -3.5 (3.2) -5.2 (1.95)* -2.4 (2.0) -6.6 (2.32)*
Two 84.3 (1.7) -7.2 (4.7) -5.0 (2.17)* -3.3 (2.3) +1.3 (2.18)
Dependent Variable Five
 
Fasting plasma glucose (mmol/l) One 4.7 (0.2) -0.35 (0.35) -0.2 (0.21) -0.2 (0.28) +0.08 (0.24)
Two 5.2 (0.4) -0.9 (0.39)* -0.6 (0.24)* -0.9 (0.34)* -0.5 (0.26)
Dependent Variable Six
 
Fasting plasma insulin (mU/l) One 21.1 (4.6) -12.0 (2.27)** -10.0 (1.3)** -9.4 (0.93)*** -9.0 (1.23)***
Two 10.2 (1.2) -8.2 (2.69)* -8.4 (1.4)*** -6.1 (1.1)*** -5.0 (1.37)**
 
Data are mean and SEM
*P<0.05, **P<0.01, ***P<0.001 compared with baseline, differences within groups. No significant differences between groups except from diastolic blood pressure at 24 months, *P<0.05).
aConfidence interval for difference between the two groups regarding changes from baseline.

Other Findings

  • After two years, 28 subjects (65%) reached weight stability with an average weight reduction of 8.5 (0.2-37.9) kg
  • 12 subjects (28%) lost 10-25%, eight subjects (18.6%) lost 5-10% and eight subjects (18.6%) lost 0-5%, four subjects (9.3%) gained 0-8% and 11 subjects (26%) dropped out. 
Author Conclusion:
  • Difficult to create homogeneous groups
  • Despite difference in intensity of treatment between the two groups, no significant difference between two groups in weight reduction
  • High attendance over time was associated with higher weight reduction
  • Subjects appreciated continuous feedback, which may improve results
  • Treatment with VLCD and an active follow-up treatment seem to relate to long-term weight-maintenance success, where rapid and major weight reduction was suggested to be an important motivation factor
  • No significant difference in dropout rates, but long holidays, such as Christmas and during summer time, were critical times for dropout
  • 10-year follow-up period desirable
  • Patient's readiness to change health behavior an important factor and should be screened for to target those most likely to be successful.
Funding Source:
University/Hospital: Karolinska Institute, Uppsala University
Reviewer Comments:
  • Article fairly easy to read and understand
  • Statistics presented in easy to understand manner and consistent with what was proposed
  • Described in such a way as to be fairly easily replicated and appears to be generalizable to the greater population of obese persons
  • VLCD component to stimulate more rapid weight loss initially appeared to have been motivating factor, followed by behavior modification, nutrition counseling and continual communication.
Quality Criteria Checklist: Primary Research
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? No
  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) Yes
  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.) N/A
  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.) No
  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? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  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