SHIFT-TB: Nutrition Intervention and Evaluation
Community-Based Nutrition Intervention for Adults With Malnutrition in Cambodia: A Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Trial
The goal of this trial is to evaluate a community-based nutrition intervention for adults in Cambodia who are underweight or overweight/obese. This study will examine the effects of the nutrition intervention on participants' dietary diversity and will also assess how acceptable and feasible the intervention is to deliver in the community settings.
Health centers were randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a six-month, community-based nutrition intervention delivered by the Village Health Support Groups, while participants in the control group will not receive it.
Researchers will compare the two groups to determine the effect of the intervention on dietary diversity. Participants will complete study assessments at the beginning of the study, at 3 months, and at 7 months.
調査の概要
詳細な説明
This Hybrid-Type 1 effectiveness-implementation cluster randomized trial will be conducted in two provinces in Cambodia. Health centers will serve as units of randomization and will be allocated to either the intervention or control arm.
The primary aim of the study is to evaluate the effectiveness of a community-based nutrition intervention in improving dietary diversity among adults with underweight or overweight/obesity. Concurrently, the study also aims to examine the implementation evaluation of acceptability, adoption, appropriateness, feasibility, fidelity, and implementation cost of the intervention
The intervention will be delivered primarily by Village Health Support Groups with support and supervision from the health center staff. The implementation evaluation will use quantitative and qualitative methods to understand how the intervention is delivered and experienced and to identify factors that may influence its future implementation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Siyan Yi, PhD
- 電話番号：+65 8753 3823
- メール：siyan@nus.edu.sg
研究場所
-
-
Phnom Penh
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Phnom Penh、Phnom Penh、カンボジア
- 募集
- Khmer Hiv/Aids Ngo Alliance
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 20 years or older
- Underweight (BMI <18.5 kg/m²) or overweight/obese (BMI ≥25 kg/m²)
- Residing in a selected study village
- Able and willing to provide written informed consent
Exclusion Criteria:
- Unable to provide informed consent
- Currently pregnant or within six months postpartum
- Planning to move out of the study area during the intervention period
- Having medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
研究計画
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：他の
- 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 |
|---|---|
|
介入なし：コントロール
|
|
|
実験的：Community-Based Nutrition Intervention
|
The nutrition intervention will be delivered over six months and will comprise four core components: (1) capacity building and ongoing support for VHSGs and health center staff; (2) nutrition education and behavior-change support; (3) continued reinforcement and follow-up; and (4) ongoing monitoring, referral, and linkage to care. Health center staff will receive a half-day of training delivered by operational district officers. Subsequently, health center staff will train the VHSGs. Following this capacity-building training, community-based delivery will proceed through three phases: initial group sessions at M0 and M1, active reinforcement from M2 to M4, and maintenance from M5 to M6. Core intervention components and content will be standardized across intervention sites. Group nutrition education sessions are delivered to enrolled participants and, where applicable, to household food decision-makers. |
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 |
|---|---|---|
|
Minimum dietary diversity
時間枠：Month 3 and Month 7
|
Minimum dietary diversity will be assessed using the Diet Quality Questionnaire (DQQ). Participants will be classified as meeting or not meeting minimum dietary diversity based on consumption of at least 5 of 10 defined food groups during the previous day or night. |
Month 3 and Month 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Mass Index (BMI)
時間枠：Month 3 and Month 7
|
BMI calculated as weight in kilograms divided by height in meters squared (kg/m²). |
Month 3 and Month 7
|
|
Waist Circumference
時間枠：Month 3 and Month 7
|
Waist circumference measured in centimeters using standardized anthropometric procedures. |
Month 3 and Month 7
|
|
Nutrition Knowledge Score
時間枠：Month 3 and Month 7
|
Nutrition knowledge will be assessed using the study questionnaire. Total scores range from 0 to 10, with higher scores indicating greater nutrition knowledge. |
Month 3 and Month 7
|
|
Health-Related Quality of Life: EQ-5D-5L Utility Index
時間枠：Month 3 and Month 7
|
Responses to the EQ-5D-5L will be converted to utility index values using the Vietnamese EQ-5D-5L value set. Possible values range from -0.5115 to 1, with higher values indicating better health-related quality of life. |
Month 3 and Month 7
|
|
Self-Rated Health: EQ Visual Analogue Scale
時間枠：Month 3 and Month 7
|
Self-rated health measured using the EuroQol visual analogue scale (EQ-VAS). Scores range from 0 (worst health imaginable) to 100 (best health imaginable); higher scores indicate better self-rated health. |
Month 3 and Month 7
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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?
IPD プランの説明
There is currently no plan to share de-identified individual participant data with researchers outside the study team.
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
米国FDA規制機器製品の研究
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