Hypertension

MNT: Weight Management (2015)

Citation:

Noda K, Zhang B, Iwata A, Nishikawa H, Ogawa M, Nomiyama T, Miura S, Sako H, Matsuo K, Yahiro E, Yanase T, Saku K. Lifestyle changes through the use of delivered meals and dietary counseling in a single-blind study. Circ J. 2012; 76: 1335-1344.

PubMed ID: 22739083
 
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:

To examine the effect of dietary counseling and delivery of calorie-controlled meals on body weight in Japanese men and women with type 2 diabetes and hypertension.

Inclusion Criteria:
  • Outpatient of Fukuoka University Hospital and Yuai Hospital in Fukuoka City
  • Men and women
  • Age 20 years or older
  • BMI higher than 20
  • Type 2 diabetes including impaired glucose tolerance and essential hypertension
  • Capable of eating three times a day
  • Informed consent.
Exclusion Criteria:
  • Allergies to common foods
  • Stroke or MI within the past three months
  • End-stage renal disease with hemodialysis
  • Cancer or receiving treatment for cancer
  • Inability to eat or digest food
  • Secondary obesity
  • HbA1c higher than 12% as defined by the Japanese Diabetes Society scale
  • BMI less than 20
  • Height more than 180cm.
  • Intention to lose weight or change smoking habits during the study period
  • Pregnant or lactating women.
Description of Study Protocol:

Recruitment 

Outpatients at Fukuoka University Hospital and Yuai Hospital.

Design  

Randomized clinical trial.

Blinding Used

Physicians were blinded to assignment of dietary counseling and body weight measurements but not blood pressure measurements.

Intervention

  • Two-phase study with participants randomized to dietary counseling by RD at Week Zero:
    • Weeks Zero to Four (self-selected diet):
      • Group A: No counseling
      • Group B: With counseling
      • Group C: No counseling
      • Group D: With counseling.
    • Weeks Five to Eight (self-selected breakfast with lunch and dinner meals delivered Monday to Friday and self-selected meals on Saturday and Sunday):
      • Group A: No counseling
      • Group B: No counseling
      • Group C: With counseling
      • Group D: With counseling.
  • Meals:
    • Meal calories based on each participant's ideal body weight and physical activity level:
      • Prescribed daily calorie levels :
        • 1,200 calories
        • 1,633 calories
        • 1,800 calories.
      • Delivered meals at lunch and dinner were provided by a healthcare food service company and contained:
        • 400 calories (1,200-calorie level)
        • 533 calories(1,633-calorie level)
        • 600 calories (1,800-calorie level).
      • Breakfast was self-selected
      • If participant required more than 1,800 calories, self-selected foods supplemented the delivered meals.
    • Each delivered meal contained less than 3g of salt
    • Participants documented dietary intake on daily records.
  • RD intervention:
    • Dietary and exercise habits assessed with a self-administered frequency questionnaire (FEFQ).
    • Counseling sessions:
      • One 30-minute to 60-minute session at the beginning of each phase for those randomized to counseling
      • One 10-minute to 20-minute phone call mid-phase for those randomized to counseling
      • Dietary advice provided during counseling focused on FEFQ results and good nutrition principles, meal planning, calories and alcohol consumption. Meal planning during the self-selected period used the Food Substitution Table for Diabetes Mellitus of the Japan Diabetes Society.
    • Performed anthropometric measurements except blood pressure assessment.

Statistical Analysis

  • Analysis of variance using linear mixed model assessed changes in continuous variables compared to baseline
  • Analysis of covariance assessed differences between groups at baseline
  • Likelihood-based ignorable analyses using linear mixed models for longitudinal data assessed the combined effects of counseling and delivered meals on anthropometric measurements and glucose concentrations
  • Intention to treat
  • Sample size calculation suggested 174 participants were required
  • Significance: P<0.05.

 

Data Collection Summary:

Timing of Measurements

  Week  0 Week 2 Week 4 Week 6 Week 8
FEFQ x        
Dietary counseling x x x x  
Height x        
Weight x   x   x
Waist circumference x   x   x
Blood pressure x   x   x
Heart rate x   x   x
Plasma lipids x   x   x
Blood cell count x   x   x
Urinalysis x   x   x
Liver function tests x   x   x
Serum chemistries x   x   x
HbA1c x   x   x
Glycoalbumin x   x   x
Adiponectin x   x   x

 

Dependent Variables

  • Primary: Change in body weight during the self-selected meals phase and delivered meals phase with and without dietary counseling
  • Secondary:
    • Changes in the following with and without dietary counseling:
      • Waist circumference: Measured halfway between the lower rib and the iliac crest at the level of the navel
      • Blood pressure
      • Blood sugar (fasting)
      • Glycoalbumin (fasting)
      • HbA1c (fasting)
      • Serum lipids (fasting).

Independent Variables

  • Nutritional counseling
  • Delivered meals.

Control Variables

  • Age
  • Sex
  • Hypertension
  • Type 2 diabetes
  • Smoking
  • Dyslipidemia.

 

Description of Actual Data Sample:

Initial N

N=200 (97 males, 103 females):

  • Group A: N=50
  • Group B: N= 50
  • Group C: N=50
  • Group D: N=50.

Attrition (Final N)

  • N=187:
    • Group A: N=47 
    • Group B: N=44 
    • Group C: N=48 
    • Group D: N=48.
  • Reasons for withdrawal for all groups included:
    • Withdrew consent
    • Met exclusion criteria
    • Discontinued due to illness or accident
    • Lost to follow-up. 

Age

Range of 22 years to 72 years:

  • Group A: 65.6±11.4 years
  • Group B: 64.0±12.5 years
  • Group C: 65.9±12.7 years
  • Group D: 64.5±10.6 years.

Ethnicity

Japanese.

Other Relevant Demographics

  • No differences among groups at baseline for the following:
    • Metabolic syndrome characteristics:
      • High waist circumference
      • High triglycerides
      • Low HDL-cholesterol
      • High blood pressure
      • High blood glucose.
    • Coronary heart disease risk factors:
      • Hypertension
      • Type 2 diabetes
      • Smoking
      • Dyslipidemia.
    • Complications from coronary heart disease and cerebrovascular diseases
    • Physical activity levels.
  • Prevalence of hypertension: N=157 (78.5%)
  • Prevalence of type 2 diabetes: N=97 (48.5%)
  • Prevalence of both hypertension and type 2 diabetes: N=54 (27%).

Anthropometrics

  • Weight (kg):
    • Group A: 66.8±1.5
    • Group B: 69.6±1.9
    • Group C: 67.6±1.7
    • Group D: 64.8±1.5.
  • BMI:
    • Group A: 25.9±3.4
    • Group B: 27.3±4.8
    • Group C: 26.0±3.6
    • Group D: 25.6±3.5.

Location

Fukuoka University Hospital and Yuai Hospital, Fukuoka City, Japan.

 

Summary of Results:

Key Findings


Change in Variables at Eight Weeks (Least Square Means ±SD)
 

Variables Group A Group B Group C Group D Significance
Change in body weight (kg)

66.8±1.5

No change

69.0±1.9

↓ 0.6kg

66.7±1.7

↓ 1.98kg

64.4±1.5

↓ 0.4kg

Groups B, C and D significantly different compared to Week Zero (P<0.05).
Waist circumference (cm) 91±1

↓ 1cm

 93±2

↓ 1cm

91±1

↓ 1cm

91±1

↓ 1cm

Groups C and D significantly different compared to Week Zero (P<0.05).
Systolic BP (mm Hg) 134±3

↑ 4mm Hg

134±2

↓ 3mm Hg

130±2

↓ 3mm Hg

134±2

↓ 6mm Hg

Group D significantly different compared to Week Zero (P<0.05).
Diastolic BP (mm Hg)

 79±2

↑ 1mm Hg

78±1

↓ 2mm Hg

75±1

No change

79±1

↓ 4mm Hg

Group D significantly different compared to Week Zero (P<0.05).
HbA1c (%) 6.1±0.1

↓ 0.1%

6.0±0.2

↓ 0.1%

 6.0±0.1

↓ 0.1%

6.0±0.1

No change

Group C significantly different compared to Week Zero (P<0.05).
Glycoalbumin (%) 16.4±0.4

↓ 0.2%

16.0±0.5

↓ 0.2%

16.0±0.6

↓ 0.6%

16.2±0.4

↓ 0.1%

Group C significantly different compared to Week Zero (P<0.05).
Triglycerides (mg per dL) 145±12

↓ 4mg per dL

112±8

↓ 10mg per dL

134±13

↓ 25mg per dL

144±13

↑ 4mg per dL

Group C significantly different compared to Week Zero (P<0.05).
HDL-cholesterol (mg per dL)

53±2

↓ 2mg per dL

58.2±2

↓ 2mg per dL

52±3

↓ 3mg per dL

59±2

↓ 2mg per dL

Groups A, B and C significantly different compared to Week Zero (P<0.05).
LDL-cholesterol (mg per dL)

105±5

↓ 7mg per dL

110±4

↓ 4mg per dL

105±4

↓ 8mg per dL

117±4

↓ 1mg per dL

Groups A and C significantly different compared to Week Zero (P<0.05).


 

  • There were no significant changes in fasting blood glucose after eight weeks compared to Week Zero for any of the groups
  • When groups receiving counseling during any period were combined (Groups B+C+D), significant reductions were observed in body weight after eight weeks when compared to Group A (no counseling), P=0.03
  • Significant differences were also observed in waist circumference, systolic BP, diastolic BP and glycoalbumin in Groups B+C+D after eight weeks compared to Group A (no P-value provided)
  • After four weeks there were no significant differences in body weight, waist circumference, blood pressure, blood lipids, blood glucose, glycoalbumin and HbA1c in any group compared to Week Zero.

Other Findings

  • Per FEFQ estimate, 82% to 84% of the participants consumed more than 10g salt daily at baseline
  • Number of counseling sessions by group:
    • Group A: Zero
    • Group B: Two
    • Group C: Two
    • Group D: Four.
  • Average consumption of delivered meals ranged from 62% to 69% across groups.

 

Author Conclusion:

The combination of dietary counseling and delivery of calorie-controlled meals may provide another strategy for reducing body weight, blood pressure and glycoalbumin in patients with type 2 diabetes and hypertension.

Funding Source:
Government: Japanese Ministry of Economy, Trade and Industry; Japanese Research Institute, Ltd.
Other: Consortium of Nissin Healthcare Food Service Co Ltd, Kyudenko Co Ltd, Yuai Hospital and the AIG Collaborative Research Institute of Cardiovascular Medicine (Fukuoka University) for the purpose of developing a new service industry associated with medical care.
Reviewer Comments:
  • Height was limited to 180cm because the delivered meals could provide a maximum of 1,800 calories and wanted to avoid replacing the deficit with self-selected foods as much as possible
  • Group B may have  experienced a carryover effect of dietary counseling during the delivered meals period
  • Duration of study was too short to reveal meaningful changes in body weight, HbA1c and lipids.
  • The inclusion and exclusion criteria did not address whether medications to manage hypertension or type 2 diabetes were allowed during the trial
  • Method of randomization was not described
  • No information was reported about what kind of dietary changes were made by the participants during the study or whether exercise was encouraged
  • The title of the paper seems misleading, implying that lifestyle changes were encouraged in addition to meal planning advice and delivered meals. Specific lifestyle changes were not described in the paper, but the authors did compare the number of times in each four-week period that the participants ate out, snacked, drank less than usual and exercised more than usual.

 

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? ???
  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? ???
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? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  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.) Yes
  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? ???
  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? 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? No
  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? ???
  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? Yes
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