The KING'S WHOLE Feasibility Study
2022年10月7日 更新者：King's College London
King's Intervention to Achieve Nutrition & Exercise Goals Supported by Lifestyle Advice for Desk-based/Work From Home Workers Delivered as a HOListic Employee Wellbeing Programme: The KING'S WHOLE Feasibility Study
Office working life has changed dramatically over the last 50 years with digitalization; this is estimated to have decreased the amount of energy (calories) used during work.
Employees who work long or irregular working hours or experience job strain are more likely to make less healthy food choices.
The combination of these factors may contribute to increased body weight during a persons working life.
The aim is to investigate the feasibility of an online lifestyle behaviour change intervention in office workers.
調査の概要
詳細な説明
Office working life has changed dramatically over the last 50 years with digitalization; this is estimated to have decreased the amount of energy (calories) used during work. Employees who work long or irregular working hours or experience job strain are more likely to make less healthy food choices. The combination of these factors may contribute to increased body weight during a persons working life. The aim is to investigate the feasibility of an online lifestyle behaviour change intervention in office workers.
This feasibility randomized control trial is a remote study and will be conducted online. Participants will be randomized to one of two health and well being interventions.
The study will last 14 weeks. Participants need to attend two on-line study appointments (at the start of week 1 and end of week 14) lasting approximately 30-45 minutes.
In weeks 2, 6 and 10 participants will be asked to participate in a personalised one-to-one behaviour change on-line advice session with a research nutritionist/dietitian. Each session will last approximately 45 minutes.
In weeks 1, 5, 9 and 14 participants will be asked to wear a wrist-worn activity monitor and report what you eat and drink for 3 days.
研究の種類
介入
入学 (実際)
28
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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London、イギリス、SE1 9NH
- Life Course Sciences
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- King's College employee (working at least 0.5 WTE)
- Work in a desk/computer-based job role
- Body mass index (BMI) that is more than 25kg/m2 and waist circumference indicative of increased cardiometabolic risk based on NHS guidelines for different ethnic groups by sex: Men - White waist circumference more than 94cm (37-in); men of Chinese, Asian, African or African-Caribbean ethnicity - more than 90cm (35.4in). Women - waist circumference more than 80 cm (31.5in)
- Sleep duration 5 - <7 hours on average on most weekdays
- Not actively loosing weight or part of weight management programme (e.g., Weight Watchers or Slimming World)
- Not under medical advice that contraindicates increasing physical activity and exercising.
- Not diagnosed with a sleep condition and have no history of chronic use of sleeping aids.
- Not diagnosed with an eating disorder.
- Not diagnosis in the last 12 months or currently requiring treatment for: heart attack, stroke, pacemaker, hepatitis or any liver disease, diabetes mellitus, chronic gastrointestinal disorders, thyroid conditions, or cancer (excluding basal carcinoma).
- No history of alcohol or drug misuse in the last 2 years.
- Own a smart phone and technology literate
Exclusion Criteria:
- - Shift worker (required to work outside 6 am and 8 pm)
- Pregnant / breastfeeding or have caring responsibilities that would prevent a participant from changing your daily routine.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Diet + Activity + Sleep
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Personalized lifestyle behavior change counselling
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アクティブコンパレータ：Diet + Activity
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Personalized lifestyle behavior change counselling
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Engagement
時間枠：14 weeks
|
Percentage of eligible volunteers consented
|
14 weeks
|
|
Attrition
時間枠：14 weeks
|
Percentage drop out
|
14 weeks
|
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Intervention adherence
時間枠：14 weeks
|
Participants complying with intervention.
|
14 weeks
|
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Intervention adherence - sleep
時間枠：14 weeks
|
Sleep hygiene adherence; Scores will range from 0 - 52, with higher scores representing poorer sleep hygiene
|
14 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body weight
時間枠：14 weeks
|
Difference from baseline to post intervention in body weight (kg)
|
14 weeks
|
|
Change in energy and macro nutrient intake
時間枠：14 weeks
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Difference in energy intake (Kcal), and sources of energy (carbohydrates, fats, and protein)
|
14 weeks
|
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Change in sleep duration
時間枠：14 weeks
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Difference in between baseline and post intervention (hours/night)
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14 weeks
|
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Change in physical activity intensity and duration
時間枠：14 weeks
|
Difference in activity from MotionWatch (duration hours in vigorous and moderate activity)
|
14 weeks
|
|
Change in sleep quality score
時間枠：14 Weeks
|
Difference in score from PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire.
Scores between 8 and 40, which are converted to T-Scores (min 28.9 - 76.5).
Higher score = more disturbance
|
14 Weeks
|
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Change in work engagement score
時間枠：14 Weeks
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Change in Utrecht Work Engagement Scale (UWES) questionnaire score.
Three subscales for "Vigor", "dedication" "absorption" - all have score between 0 and 6.
Higher scores = more vigor/dedication/absorption at work. 1 total UWEZ-9 Score.
Score between 0 and 6.
Higher score = more work engagement.
|
14 Weeks
|
|
Change in anxiety questionnaire score
時間枠：14 weeks
|
Difference in generalized anxiety (GAD-7) questionnaire score.Range 0 to 21.
Higher score = higher anxiety level.
|
14 weeks
|
|
Change in depression questionnaire score
時間枠：14 weeks
|
Difference in PHQ9 depression questionnaire score.Range 0 to 27.
Higher score = more likely depressive symptoms.
|
14 weeks
|
|
Change in reported level of burn out
時間枠：14 weeks
|
Difference in Oldenberg Burnout Inventory score, higher score = more burnout signs/symptoms
|
14 weeks
|
|
Change in day time sleepiness
時間枠：14 weeks
|
Difference in Epworth Sleepiness Scale.
Range 0 to 24 - higher score = more daytime sleepiness
|
14 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in job satisfaction score
時間枠：14 weeks
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Difference in job satisfaction questionnaire score.Score between 5 and 25.
Higher score= more job satisfaction.
|
14 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年3月7日
一次修了 (実際)
2022年9月30日
研究の完了 (実際)
2022年9月30日
試験登録日
最初に提出
2022年3月1日
QC基準を満たした最初の提出物
2022年3月1日
最初の投稿 (実際)
2022年3月10日
学習記録の更新
投稿された最後の更新 (実際)
2022年10月10日
QC基準を満たした最後の更新が送信されました
2022年10月7日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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