Randomized Controlled Trial

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POSITIVE: See Quality Criteria Checklist below.

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.

• 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.

• 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
• HbA_1c 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.

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.

 

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)
    • HbA_1c (fasting)
    • Serum lipids (fasting).

Independent Variables

• Nutritional counseling
• Delivered meals.

Control Variables

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

 

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.

 

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 HbA_1c 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.

 

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.

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.

• 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, HbA_1c 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.